Opportunity Knocks: Expanding access to early stage life science investment opportunities and what Mammoth Scientific looks for in investable portfolio companies at Series A and beyond.

A Southeast Life Sciences Q&A with Mammoth Scientific COO Kimberly Mackrill. 

 

Mammoth Scientific occupies a unique position in the world of life science investing. Its founding team, which includes experts in medical, spinal, financial advisory and fintech all found venture investing cumbersome for most investors. Mammoth is built to fund quality companies, while seeking to provide a modern, transparent and quality experience to investors who previously found access to high potential, early stage life science innovators out of reach.

 

“Financial advisors are always looking for an edge to better serve their clients,” Mammoth COO Kimberly Mackrill told Write2Market’s Paul Snyder. “One way to do that is expanding offerings beyond what’s available in the public marketplace, especially in life sciences. Many of those opportunities don’t move into the public market because they’re ultimately acquired by large organizations who innovate through acquisition. But prior to that stage in their commercial life cycle, those companies are out there with world changing ideas and sufficient financial support to continue innovating and creating the future we want to live in.”

 

Essentially, Mammoth seeks to democratize early stage investment access, enabling wealth managers to access high potential VC opportunities in the life sciences. We hope you enjoy the following Q&A with Ms. Mackrill.

 

How did you get here?

I started in the nonprofit world, focusing on finding ways to motivate people without any financial compensation. I wound up working in marketing at a publicly traded company and then pulling back from working outside of my home while I had infants. I created my own boutique marketing firm and was highly selective about who I would work with during the early years of parenting. After my partner’s company was purchased by a PE firm, my partner and I founded Mineral – a fintech and financial advisory focused on design and marketing. Mineral received Best Advisor Innovation, Fuse 2017 and XYPN Fintech Award 2018 for software we created that helps advisors onboard clients. Mineral was acquired in 2018 by a national RIA. We worked inside their firm for two years – helping them redesign their client portal and accelerate their marketing offer. 

 

Our ability to brand build and create innovation technology contributed to over $3B in increased valuation across our portfolio of experience. 


Watching the impact of private equity on the firms we’ve served throughout our careers, gave us deep insight into the way both brand and technology influence valuations. We’ve seen how equity changes the game for both companies and individuals and believe that now is the time to bring the world of private investing – specifically venture capital, into this modern, accessible landscape.

 

Where is your sweet spot investment range?

Mammoth is built for accredited investors, qualified clients and the fiduciaries who serve them. We work with Registered Investment Advisors to help overcome the potential compliance hurdles and marketing pieces that their clients need to properly understand this level of investing and how it can impact not just their own portfolio, but the broader world for good. Additionally, Family Offices and Institutional Investors are all a part of the balanced mix of investment in our fund.

Mammoth is built to invest in innovative life science companies at the Series A level and beyond. We look for companies that have maturing revenue models and proven intellectual property who need to develop clear paths to regulatory approval and reimbursement. We currently do not invest with significance in the pharmaceuticals market, but everything else life science and medtech is in play with two surgeon GPs doing significant work in due diligence.

 

What are the should haves your invested companies bring with them?

Should Haves: A clear business model, quality research, a strong and experienced team and validated intellectual property.

 

Our Value Add: Our team includes members with extensive experience in FDA and EU regulation along with determining reimbursement pathways to help guide the long term market aspirations of our portfolio companies. 

 

What turns you off when exploring a new prospect?

  • Lack of a clear perspective and unfocused leadership,
  • Inability to drive revenue with their early stage business model, and
  • Lack of patience and grit necessary to build a lasting company. Being vulnerable, admitting non-alignment and a willingness to shift or pivot in order to move forward is an underrepresented strength in founders of life science startups that need help to realize their potential. Make-or-break activities and milestones like reimbursement pathways and strategies can take multiple rounds of discussions with regulators to advance. Ultimately, we feel success is rooted in a commitment to tackle adversity head-on. We all feel those moments of mettle testing. When teams successfully meet those moments to a positive result or outcome, it is powerful to witness them come through the other side.

 

What do you wish more founders knew? 

First, the amount of time it will take for them to achieve their long term goals. Depending on the technology, life science innovations can take several years and millions of dollars to realize their exit or commercial potential and the associated returns for investors.

 

Second, the dimensions they have to understand to really see the potential of their business. 

Pure startups using friends or family for branding is often not strong or specific enough, for example. Those startups have strength and early success in other areas, but that branding and marketing dimension often does not mature at the same pace as other pieces. As such, valuations suffer, or are not indicative of real potential, because branding and marketing is lacking.

 

We look at these dimensions for our portfolio companies and investors. What needs to mature, or ‘grow up’ to play in the same space as the rest of your life science technology has to offer?

 

What common mistakes have been around too long for life science startups seeking Series A investments and beyond?

  • Lack of unique research,
  • Underinvestment in marketing and brand,
  • Failure to build a strong advisory team, and 
  • Lack of detail in long term vision and strategic roadmap. At series A and beyond, we expect potential portfolio companies to have a well developed strategic road map including product market fit, IP, regulatory pathway confidence and in some cases a pre-submission meeting with, and feedback from, regulatory bodies like the FDA. Iterating and adjusting potential process and pathway refinements and acceleration is where we can come in. 

 

What are the hallmarks of young companies that should be getting to know you?

Proven leaders, deep research, a strong understanding of the health sciences market, protected intellectual property and a vision for building a strong business.

AdvanSE 2021 is fast approaching! Will you join us?

Southeast Life Sciences thanks Ms. Mackrill for sharing her insights with us. We look forward to her keynote presentation on Thursday, October 28th at AdvanSE. Come see the best of what the southeastern U.S. life science ecosystem has to offer at the 2021 edition of our flagship event October 27 – 29 in Charleston, SC.

 

About Mammoth Scientific
Mammoth Scientific is a venture capital company that specializes in health science and technology funds. Co-founders Dr. Jay Yadav, Tommy Martin, Kim Mackrill, Dr. Matthew McGirt and Jud Mackrill provide venture capital for health science and technology companies maturing beyond seed rounds. The Mammoth team includes seasoned physician entrepreneurs and highly successful operational managers, representing a twenty-year track record of creating and investing in multiple successful start-ups with large exits to major global companies (e.g., Abbott Laboratories, Boston Scientific, Johnson & Johnson) or to the public markets. To learn more about Mammoth Scientific and its $100 million Mammoth Health and Tech Fund, visit Mammoth.vc.

The 2021 Edition of the Best the Southeast Has to Offer in Early and Late Stage Life Science Companies – Meet the 2021 AdvanSE PitchRounds Presenters

At Southeast Life Sciences one of our top priorities is introducing investors to the best the Southeast has to offer in early- and later-stage life science companies. 

 

Without further ado, meet the 2021 AdvanSE PitchRounds Presenting Companies. Each will be presenting to dozens of investors among hundreds of attendees at AdvanSE 2021 on October 28 in Isle of Palms (Charleston), SC. Registration, either in-person or virtual, is open.

 

Late Stage

Amend Surgical https://amendsurgical.com/

Amend Surgical is strategically focused on the development and commercialization of biomaterials for the oral surgical and dental market coupled with manufacturing expertise and operations capabilities for our OEM partnerships in the spine and orthopedics market. The company currently has ten employees and occupies a manufacturing and administrative space of approximately 11,000 square feet in the biotech corridor of Alachua, Florida.

 

BrightSpec http://brightspec.com/

BrightSpec is a life science tools company commercializing MRR instrumentation that bring unique and powerful analytical capabilities to pharma, chemical, and consumer end markets. Unlike others, MRR spectra can be computed using quantum chemistry; with a digital fingerprint in place of a reference sample and no separation needed, MRR brings both higher precision and speed to R&D and production processes. Commercial stage and with pipeline in hand, BrightSpec is seeking capital to achieve immediate revenue opportunities while building out AI tools, sampling methodologies, and features that will enable breakthrough science in a number of important areas.

 

CytoRecovery https://cytorecovery.com/

CytoRecovery has completed the development of a novel product system that improves the ability to rapidly sort and recovery specific live cell populations from tumor biopsies, tissue and all types of biological samples. The system is rapid, affordable and offers key advantages over the current state of the art, including speed (minutes vs. hours/days), the recovery of live, viable cells (cells are mostly recovered dead with today’s methods), and the cells are sorted and recovered without the use of markers, antibodies or other interfering mechanisms. The technology is exclusively licensed from Virginia Tech. The company has completed beta validation studies and is preparing to bring its Cyto R1 product system to market in Q1 2022.

 

Efferent Labs https://www.efferentlabs.com/

Efferent Labs offers a live, cellular data acquisition platform that will radically alter the landscape of pre-clinical research in animals. Automated, objective data collection develops clinically relevant data sets, reduces errors and bias associated with manual data collection, and provides unparalleled insight into in vivo cellular processes in animal models. We operate in a $6B market that is ripe for disruption, and our transformative technology platform will dramatically reduce R&D costs

 

Lindy Biosciences https://www.lindybio.com/

Lindy Biosciences is a development-stage company addressing formulation challenges in the rapidly growing biotherapeutics market. Our core technology, Microglassification, produces spherical, dense, stable particles of a therapeutic protein, ideal for solid injectable formulations such as high-concentration suspensions or encapsulation for controlled release. Over half of all antibody therapeutics are given intravenously, in part because the high dose required cannot be formulated as a solution in a volume small enough for subcutaneous injection. We are developing high-dose suspensions of protein that are suitable for subcutaneous injection, decreasing administration costs, increasing patient comfort and compliance, and enabling new high-dose molecules to reach the market.

 

Lumiheal Therapeutics https://lumiheal.com/

Lumiheal Therapeutics is harnessing the power of fluorescent light energy (FLE) to heal chronic and acute wounds, burns and surgical incisions, and is poised to impact $150 B in global healthcare spend. The LumiHeal® system includes a blue LED light and a patented topical component containing chromophores which converts that light into FLE. FLE photons modulate the cellular biology of the skin to support healing by stimulating mitochondrial function, angiogenesis and collagen production and reducing inflammation. LumiHeal® offers advanced therapy that is easy to use in any site of care, flexible, and extremely cost-effective compared to existing technologies.

 

Merand Pharmaceuticals

Founded in 2018, Merand Pharmaceuticals, Inc. is a clinical stage, privately held Charlottesville, VA corporation (Delaware registered), which is developing microRNAs for unserved vascular diseases. Its first product targets patient populations with poor blood flow to the extremities, such as those suffering from peripheral artery disease (PAD). The Company has recently completed a pre-IND meeting with the FDA and is completing the work needed to begin its first-in-human studies in early 2022. Merand believes that its product has the potential to be disease modifying, unlike the current available therapy, and thus could be eligible for Breakthrough Therapy designation and accelerated approval.

 

Moterum https://moterum.com/

 

Obsidio https://www.obsidiomed.com/

Obsidio, Inc. is a venture-backed medical device company pioneering a biomaterial platform technology to enable minimally-invasive occlusion of blood vessels with broad applications in interventional radiology and interventional oncology. The technology can be used to control bleeding, close off vessels supplying blood to tumors, eliminate abnormal connections between arteries and veins, and treat aneurysms.

 

Oxidien Pharmaceuticals https://oxidien.com/

Oxidien is a clinical stage biopharma company with an opportunity to transform care for people with recurrent kidney stone disease by treating secondary hyperoxaluria, a large unmet medical need for which there are no approved therapies. Oxidien has compelling clinical data and is now seeking $12M to achieve phase 2 data read-out, which could yield a significant return for investors and multiple strategic or go-forward financing options.

 

TearSolutions https://tearsolutions.com/

TearSolutions is a clinical stage biotech company. Our lead product, called Lacripep, is a potentially disruptive therapy in the $6B+ Dry Eye market, providing the speed of a steroid but the safety and comfort profile of an over-the-counter. Lacripep has impressive first-in-human clinical data where, within two weeks, we demonstrated a clinically and statistically significant improvement in both a sign and symptom of Dry Eye in a dose ranging Phase IIa trial in more than 200 patients. We have a defined clinical and regulatory path that FDA is aligned with that will lead to a general Dry Eye and Sjogren’s Dry Eye indication, which is unique for this market and represents significant upside potential for the Company. We are actively raising $22M to move Lacripep into a Phase III study while optimizing manufacturing to get Lacripep ready for commercialization.

 

Theradaptive https://www.theradaptive.com/

Theradaptive is an MIT spin-out developing a therapeutic delivery platform for targeted tissue regeneration with a total addressable market of over $10B in several clinical indications. The platform was conceptualized by the organization’s founder, Luis Alvarez, PhD, during and following a combat tour in Iraq where several of his soldiers suffered severe extremity injuries. Using a proprietary method, Theradaptive can convert any recombinant protein into a variant that can be “painted” onto medical devices. This makes it possible to coat implants, devices, and injectable carriers to deliver a therapeutic directly to where it is needed most.

 

Early Stage

 

AAD https://www.qscoutlab.com/

AAD is a point-of-care diagnostics company that provides information to drive fast health decisions. The company has developed the only automated system capable of quantitating an early marker for sepsis, immature band neutrophils. AAD’s rugged lab-in-a-box produces hematology results patient-side in about 2 minutes from a fingerstick or venous blood. Whole blood is added to the test with no sample prep or need for wet reagents used in traditional hematology instruments. Results are displayed onscreen and can be stored in a cloud data application that can integrate with electronic health records and lab information systems.

Because 87% of sepsis starts outside the hospital, having rapid results outside hospital settings or in the emergency department (ED) can help with faster detection and response. Despite its power, an automated method to quantitate bands remains elusive and can only be done manually, which is not practical in ED triage and out of the question in pre-hospital settings. Manual quantitation of bands can take about 2 hours for STAT results in a hospital. Rapid results are important because mortality increases nearly 8% for each hour delay in treating septic shock.

 

Acomhal Research https://www.acomhalresearch.com/

Despite all the efforts and progress in early detection and development of novel treatments, cancer still remains the second leading cause of death in the US, with ½ million cancer patients dying each year. Tumor recurrence following treatment and metastases are the main causes of cancer-related deaths. We now know tumors comprise a subpopulation of cancer stem cells that are both resistant to current treatments, including radiotherapy and chemotherapy, and capable of escaping primary tumors to colonize other organs and form metastases. 

 

At Acomhal Research, we developed a novel peptide drug that can specifically eradicate these cancer stem cells in glioblastoma (GBM), the most common and deadly brain tumor, which has no cure and leaves patients with a median survival rate of only about one year. Acomhal was awarded an NIH/NCI Phase I STTR plus a matching grant from the Virginia Center for Innovative Technology (CIT) to develop biodegradable nanoparticles to encapsulate its peptide drug for sustained delivery, and resulting preclinical work demonstrates the efficacy of these nanoparticles in specifically killing GBM cancer stem cells in vivo. Recently, Acomhal received seed funding from local investors, and is currently working with a regulatory drug development company to prepare for a pre-IND meeting with the FDA in 2022. IND-enabling studies will be conducted during the next 1-2 years before initiation of a Phase I clinical trial. Acomhal expects these nanoparticles will be commercialized within 5 years to initiate Phase II and III clinical trials, and we will seek acquisition or sublicensing by a pharmaceutical company. As cancer stem cells are also found in many types of cancers, including breast, lung, colon, pancreatic, ovarian and prostate cancer, Acomhal Research will expand its therapeutic platform technology to other cancers, providing the opportunity to extend lifespans in patients suffering from various types of tumors.

Alveolus Bio  https://alveolusbio.com/

Alveolus Bio is a team of scientists, physicians, and innovators pioneering breakthrough FDA-approved targeted therapeutics for chronic lung diseases. Our clinical pipeline includes preclinical phase biotherapeutics for Chronic Obstructive Pulmonary Disease (COPD), Idiopathic Pulmonary Fibrosis (IPF), Bronchopulmonary Dysplasia (BPD), and Pulmonary Arterial Hypertension (PAH).”

Ares Immunotherapy https://aresimmunotherapy.com/

Ares Immunotherapy is a cellular immunotherapy company with a platform technology for the treatment of solid tumors. Our intellectual property is based on a unique subset of CD4+CD26hi T-cells that deliver substantial improvements in a solid tumor setting and a shortened manufacturing process that reduces risk and cost of goods. Across every measure we have tested, both in vitro and in vivo, our technology is far superior to anything currently available. Our potent anti-tumor response is driven by an increased cytokine secretion, improved homing and migration, and prolonged in-vivo persistence powered by a resistance to apoptosis and stemness properties. The technology is a platform that can generate products across all T cell modalities including chimeric antigen receptor (CAR) T cells, enhanced T cell receptor (eTCR) therapies and can be used to isolate high potency Tumor Infiltrating Lymphoctyes (TILs). Our lead candidate is a CAR-T cell targeted against mesothelin. In animal studies, across multiple solid tumor types, we have shown a tremendous increase in efficacy compared to conventional CAR-T, leading to increased levels of tumor regression even up to full tumor elimination. Data to date shows that our therapy can lead to a greater quality of life and survival rates for individual with mesothelioma, pancreatic cancer, lung cancer and more. We are preparing for a first in man trial in mesothelioma followed by subsequent trials in other mesothelin containing solid tumors. We have a best-in-class lineup of advisers and an experienced team with decades of cell therapy development experience. 

Blink Science https://blinkscience.com/

We’re developing an ultra-accurate, low-cost test strip and a handheld reader with the potential to deliver lab-quality diagnostic results in seconds for infectious diseases like COVID-19, heart attacks, cancers, brain injuries, and much more. Our goal is to bring affordable, near-instant testing and a full suite of personal health technologies to more than a billion underserved families around the world.

Deep Reasoning

Deep Reasoning AI Inc. has developed technology to automate the generation of patient-specific, 3D (three-dimensional) anatomical models from standard medical imaging modalities such as CT and MRI. Our core technology, the Deep Reasoning Engine, combines AI reasoning, deep learning, knowledge representation, and optimization to solve complex tasks, typically in an unsupervised or weakly supervised setting. The technology has been developed based on 10+ years of research work by two of the Company’s Co-Founders, Carla Gomes, the Ronald and Antonia Nielsen Professor of Computing and Information Science and the director of the Institute for Computational Sustainability at Cornell University and fellow Co-Founder, Bart Selman, the Joseph Ford Professor of Engineering and Computer Science at Cornell University and the President of the Association for the Advancement of Artificial Intelligence (AAAI).

 

The Company is currently working with the Mayo Clinic to validate our technology in a clinical application. We have received positive feedback from our collaborators at the Mayo Clinic that our models are highly accurate, save weeks of expert time, and are helpful for patient education, medical training, and operative planning.

 

Elastrin https://www.elastrin.com/ 

We are a South Carolina Biotech developing a groundbreaking innovation to reverse damage to elastin, hence our name Elastrin. At least one billion people suffer from life threatening diseases linked to damaged elastin. So, what is elastin and why is it important? Elastin is one of the main components of blood vessels and lungs, allowing them to circulate blood and oxygen. As we grow older – actually as early as 25 years old – elastin gets damaged. Just like a rubber band, they grow thin and snap. This process triggers hardening of the arteries and lung damage, leading to cardiovascular and lung diseases. Our drug-loaded nanoparticles can reverse that process, as if we were travelling back in time. And even better, they selectively go to sick tissue alone, making them safer and more effective. With the help from South East Life Sciences, we hope to gain broad recognition for what our therapy will mean to billions of people. But bringing new therapies to the market is challenging. It will take many millions to test our drug during clinical trials and regulators are making sure it’s safe to use for everyone. We have the ambitious goal to serve patients in need as soon as 2027 and believe this will be a revolution in healthcare. One of the puzzle pieces towards healthy aging. We always say: “we don’t want to live forever, but do we want to live forever healthy”. 

 

Evren Technologies https://www.evrenvns.com/

Evren Technologies is advancing the treatment of PTSD through a user-friendly and intelligent hardware and software platform that is easy to use and personalized. Our initial medical device – the Phoenix ® – delivers transcutaneous auricular vagal nerve stimulation (taVNS) in a discreet earbud design. Pairing the Phoenix with our PTSD symptom tracking app will allow for reimbursable remote clinician monitoring and the establishment of a leading PTSD database that collects biosignals, symptom tracking, triggering events, and therapy effectiveness.

 

Hub Hygiene https://www.hubhygiene.com/

Hub Hygiene, Inc. is an Atlanta-based medical product manufacturer spun out from Georgia Tech in 2017 and now financially backed by BASF and Children’s National to develop easySCRUB, a patented and award-winning, microporous polymeric foam technology for medical applications. We are currently undergoing Category I medical device packaging, sterility and biocompatibility testing with expected FDA clearance for human use by Q4/2021.

 

iBodyTec https://www.ibodytec.com/

We manufacture an Electric-Muscle-Stimulation bodysuit with integrated Biosensors. In connection with a motivational tele-health platform to improve health and fitness. Our practitioners will find our system useful to apply TENS or EMS application in person or virtual. We want to close the gab between rehabilitation and fitness.

 

Karios Technologies

Karios Technologies has a novel patented technology platform that we have spun out of UCLA-UCSD. Our technology is supported by 3 patents and 4 scientific publications (the most recent was June 2021 Nature Communications). We are first using our technology to prevent postsurgical adhesions with a cardiac focus, and then will translate our product into other surgeries as well as use for surgical sealants, hemostatics, and drug/cell delivery. We are raising a seed round to enable clinical studies of our clinical prototype.

 

Lena Biosciences https://www.lenabio.com/

Lena Biosciences is a biotechnology company focused on saving people’s lives by identifying which cancer drugs work best for their particular cancer.

 

Liora Biologics https://liora.global/

Liora Biologics holds the exclusive license to the NELL1 variant for veterinarian applications. Nell1 is an extracellular signaling protein expressed in embryological and early neonatal development. Nell1 has the ability to potentially return damaged tissue, bone, and tendons to their original form and function with no scaring. While healing, NELL1 signals the body to control inflammation in the disrupted area.

Our target indication is the treatment of injured tendons in horses, following by companion animals. Our team is comprised of global experts in business, regulatory, science, and the veterinary field. We look forward to showing you the passion, drive, and expertise of Liora. Whose focus is the veterinary field which is so often overlooked by the biotech industry.

 

NeuraStasis https://www.neurastasis.com/

At NeuraStasis, we’re developing a new neurostimulation device for stroke patients. Every single day, 1000 people will become permanently disabled due to a stroke in the United States. Treatments exist at specialty stroke centers, but often we can’t get patients to treatment fast enough. In stroke, time is brain. Every minute the brain is deprived of blood flow, millions of neurons are lost. Each minute a patient waits for treatment matters.

As NeuraStasis, we fill in the gaps in treatment. Our non-invasive, easy-to-apply solution uses proprietary electrical stimulation to places neural tissue into stasis – preserving brain functionality. Applied between the time of diagnosis and treatment – we’re a bridge to care – acting as a pause button to give physicians and patients more time. Applying our device, during these precious minutes, could increase the number of patients that receive treatment, reduce outcomes of serious, long-term disability, reduce long-term costs for these patients.

Spun out of the Texas Medical Center’s Innovation arm, NeuraStasis is led by an interdisciplinary founding team. We have just started the Zeroto510 medical device accelerator out of Memphis, TN and are focused on rapidly moving our technology towards early feasibility studies.

 

OncoSpherix https://oncospherix.com/

OncoSpherix is developing proprietary first-in-class small molecules that disrupt the function of the transcription factors HIF-1 and HIF-2 (hypoxia-inducible factors), thereby crippling the ability of cancer cells to adapt and spread from regions of low oxygen (hypoxia). By blocking the function of HIFs, OncoSpherix compounds inhibit expression of genes that bring in new blood vessels (angiogenesis), drive tumor invasion and metastasis, and aid in tumor cell survival and spread. Many types of cancer utilize both HIF-1 and HIF-2 for their adaptive response to hypoxia, so the dual inhibition of both forms is advantageous over agents that inhibit a single form. HIF inhibition prevents expression of genes that bring in new blood vessels (angiogenesis), drive tumor invasion and metastasis, and aid in tumor cell survival and spread.  OncoSpherix’s leadership team has deep experience in tumor biology, medicinal chemistry, oncology, pharmaceutical drug development, biotechnology company value creation and financing.

 

OrbitalRX https://orbitalrx.com/

OrbitalRX is a B2B cloud-based SaaS providing novel data integration and workflow automation to reduce hospital drug spend (up to 30%) and labor investment (at least 50%) associated with medication supply disruption, while also reducing patient safety risk. Every year hospitals spend over $750MM dealing with the impact of medication supply chain disruptions. Commonly called “drug shortages”, these events appear multiple times per week and sustain for weeks, months or years, affecting every hospital in the country (and overseas). Our initial focus as a company is to give hospital leaders all of the data and tools that they need to prevent these unpredictable supply disruptions from impacting care and outcomes. We have seen success in this and are graduating our focus to contribute to the broader national effort to reduce the instance and severity of these events while continuing to support hospitals in maintaining healthy supply chain performance.

 

Perfusion Medical

Perfusion Medical is commercializing PEG-20k, an IV solution invented at Virginia Commonwealth University. The solution restores oxygen tissue delivery in patients who have lost blood (e.g. hemorrhagic shock, ischemic re-perfusion injury) or are undergoing procedures where the blood supply is diminished. In large animal trials the solution worked 10 to 20 times better than current standards of care dramatically increasing survival rates. The solution is pre-clinical and the company anticipates having its first FDA approval in 2024. PEG-20k is protected by 4 issued patents, and multiple international applications. PEG-20k may be the most dramatic breakthrough in trauma and critical care in decades, could help millions of patients and generate one billion dollars a year in sales or more. The solution represents a major medical breakthrough and paradigm shift.

PEG-20k has been developed at Virginia Commonwealth University over the past decade with $12 million in support from US Army MRDC and was licensed by Perfusion Medical, a VCU spin out company. Perfusion Medical is committed to taking PEG-20k through the commercialization process, enabling the solution to be FDA approved and made broadly available through the medical supply chain – saving patients suffering from trauma and other related illnesses. Perfusion Medical is a Virginia LLC and raised a $500,000 seed round in 2020. The company is currently pursuing non-dilutive funding from the DoD, NIH and other agencies and was recently awarded a NIH Phase 1 STTR grant for $250,000. The company is working with DataRevive (FDA consulting) to prepare a pre-IND submission. The company is seeking to raise $2 million for the Phase I safety study and a Phase IIa proof of concept study.

 

Plakous Therapeutics https://www.plakoustherapeutics.com/

Plakous Therapeutics is a preclinical biotech firm. We have developed patented methods to extract and preserve the cytokines and growth factors stored within the human placenta. Our method yields a shelf stable, acellular mixture with high, consistent, and predictable concentrations of proteins (both cytokines and growth factors) stored within the placenta.
Our first indication is for the prevention of the rare pediatric disease Necrotizing Enterocolitis (NEC). We have also generated compelling data in osteoarthritis, wound healing, nerve injury, and other inflammation driven and aging related degenerative disease states; however, the unmet medical need and the regulatory efficiencies of NEC as a rare pediatric disease have led us to prioritize the NEC development effort. Our intent is to bring Protego-PD to market for NEC, while actively pursuing grant funding to develop other indications.

 

Polaris Genomics https://trugenomix.com/staging/8156/

Polaris Genomics is propelling modern behavioral healthcare toward a long-overdue dawn of precision medicine through genomic sequencing, genetic testing, & TruNorth™, our AI/ML engine that integrates & analyzes multi-omic data.

 

PreTel https://pretelhealth.com/

PreTel is focused on improving clinical and health economic outcomes of pregnancy by developing a rapid determination of labor status based on revolutionary patented wearable biosensors that diagnose and improve the management of preterm labor and provide dosing guidance during the induction of labor. Patented clinical decision tools assist labor and delivery clinicians in the management of preterm labor and reducing C-section delivery. PreTel has developed patented wearable sensors that isolate and detect uterine signals from independent regions. An intelligent analysis of the relationship of these signals determine true versus false labor – that is displayed in real-time. The accurate diagnosis supports the needed management of the pregnancy improving neonatal outcomes. The monitoring system can be configured for home use to support preterm labor management.

 

Stomagenics https://stomagienics.com/

Stomagienics provides solutions to chronic and acute health challenges faced by survivors of colorectal cancer and Crohn’s disease who undergo ostomy surgery. Stomagienics has patented technologies across the spectrum of care including a single-use disposable product that helps a patient perform a more hygienic pouch change, and a prosthetic device that helps patients care for inflamed or damaged peristomal skin. The StomaGenie pouch replacement cartridge is approved for reimbursement by Medicare and we have recently signed agreements with two of the leading distributors in ostomy supplies.

Trace Orthopedics

Trace Orthopedics has invented a low-cost medical device, and minimally invasive method to reattach partially torn tendons to bone. The specially designed tendon fastener is inserted through a 10 gauge needle using imaging guidance. Rather than in an OR, the Trace procedure can be performed in a doctor’s office or an imaging suite. This effectively reduces surgical morbidity, is up to four times faster, and returns the patient to activity in half the time. The company is focused on gluteus medius tendon reattachment, before moving on to other indications around the hip, upper, and lower limbs. Radiologists specializing in ultrasound-guided intervention will be able to perform this repair technique percutaneously using only mild sedation. Surgeons can perform repairs faster than open surgery or arthroscopy, allowing them to multiply their revenue. This enables effective treatment for cases that are not referred for surgery, restoring vitality for partial tendon tear patients.

 

TriAltus https://trialtusbioscience.com/

TriAltus is a life science tools company formed to commercialize patented protein purification technology with breakthrough utility across a wide range of applications. Our affinity purification consumables and recombinant proteins are gaining enthusiastic users among academic and industry scientists at Merck, Amgen, Harvard, UC Berkeley, and many others.

 

URO-1 Medical https://www.uro1medical.com/

URO-1 creates solutions to improve the diagnostic accuracy of prostate biopsy in men and clinical outcome in the treatment of overactive bladder (OAB) in women. In prostate biopsy, the company has completed development of the SUREcore prostate biopsy needle and the coreCARE tissue specimen retrieval kit, both of which are cleared to market. Initial clinical studies have validated design goals with results that exceed expectations. Development of two other biopsy instruments is ongoing. Expanded applications for the biopsy portfolio will include all soft tissue biopsies, of which 20M are performed annually worldwide.

In OAB, the FDA- cleared Repris Bladder Injection System is used to inject onabotulinumtoxinA (BOTOX®) and has been demonstrated to reduce the incidence of urinary retention, the most common post procedure complication that has hindered broader adoption. 15.7M American women between 40 and 80 years of age have OAB. Expanded use of the instrument includes a new generation of pharmaceuticals to treat bladder cancer and stress urinary incontinence. The system is cleared to market with design goals validated in over 200 procedures. To summarize, the company has 3 market ready products with 2 additional products to be market ready within 6 months.

Meet the AdvanSE 2021 Keynote Speakers

We’re now officially less than one month away from the 2021 edition of Southeast Life Science’s flagship event, AdvanSE. The program is now complete. Please take a moment to meet our keynote speakers.  

 

Dr. Michal Preminger 

Head Eastern North America

Johnson & Johnson Innovation

 

Dr. Preminger will moderate our investor keynote lunch on Thursday, October 28. The investor panel will review data provided earlier in the day by Silicon Valley Bank, in addition to sharing how Covid has changed the life science investor landscape.

 

Michal is head of Johnson & Johnson Innovation, East North America, located at the Innovation Centre in Boston. She leads a team building, advancing and managing the External R&D portfolio of co-investments spanning across the pharmaceutical, consumer health and medical devices sectors. 

 

Pierre Theodore

Vice President of Global Health

Johnson & Johnson

 

Pierre highlights our SE Color keynote panel on Thursday at 2:00 p.m. The panel will focus on health equity, particularly as it affects the bottom line for small and large companies. 

 

Pierre is a thoracic surgeon responsible for helping accelerate novel technologies to advance the standard of care in the surgical management of patients worldwide. He serves on the adjunct surgical faculty of Stanford Medical Center. He has over 20 years of experience in cardiothoracic surgery, surgical education and innovation with a focus on global surgery initiatives to expand surgical capacity in low and middle income countries.

 

Kim Mackrill

COO

Mammoth Scientific

 

Kim will speak on Thursday as well as our Women @ SLS featured keynote session. She is co-founder of Mammoth Scientific, a health science and technology venture capital firm that announced the launch of a $100 million venture fund in June 2021.

 

Kim serves as the organizational integrator at Mammoth with a strong focus on aligning the interests of the investment advisor, fund manager, investors and portfolio company founders. Kim creates different processes to conceptualize and develop solutions for problems facing businesses and their customers. She helps portfolio companies integrate data and technology to help them deliver proprietary experiences for their customers. 

 

Dr. Vivian Lee

President of Health Platforms

Verily Life Sciences

 

Dr. Lee will deliver the AdvanSE 2021 closing keynote on Friday, October 29 at 12:30 p.m. Her talk will focus on solving the U.S. healthcare crisis and include an interview with Tina McKeon, Ph.D., a partner in the life science industry with Kilpatrick Townsend. 

 

Dr. Lee (M.D., Ph.D. and MBA) is author of The Long Fix: Solving America’s Health Care Crisis with Strategies that Work for Everyone (Norton). A physician and healthcare executive, Dr. Lee also serves as a senior lecturer at Harvard Medical School.

 

Sean Slovenski

CEO

BioIQ

 

Sean will deliver the morning keynote on Friday, October 29 at 8:30 a.m. Sean is a healthcare industry leader with over 30 years of experience. He is a proven senior executive and entrepreneur with experience in small, medium and large companies. Mr. Slovenski started his career helping to build, then lead, one of the nation’s first large-scale wellness efforts for Fortune 500 clients. Anticipating wide-spread usage of the Internet Sean pioneered the development and delivery of wellness coaching online by inventing the first-of-its-kind personal coaching product MyHealthCoach.com. He then co-founded and served as CEO of Hummingbird Coaching Services, which was acquired by Humana in 2010.

 

Are you ready to discover the best the southeast United States has to offer in life science innovation? Investors, are you ready to find your next investable opportunity? Innovators, are you ready to meet your next investors or solution providers? 

 

Registration

 

Register now for the 2021 edition of our flagship event, AdvanSE, October 27-29 at the Wild Dunes Hotel in Isle of Palms (Charleston), South Carolina. Note: ​​After careful consideration and consultation with internal and external health and safety experts, Southeast Life Sciences has decided to require all attendees and staff to be fully vaccinated* to attend the event.

 

Here is a look at the AdvanSE 2021 breakout sessions.

 

About Southeast Life Sciences

 

Born from the merger of the Southeastern Medical Device Association (SEMDA) and Southeast Bio in 2019, Southeast Life mission is to cultivate, convene, and connect the Southeast entrepreneurial ecosystem to foster life science innovation & investment across the region for the greater good. We facilitate connections, conversations and capital investments through continuous networking, education and funding opportunities for life-science innovators of all shapes and sizes. 

One Month To Go! Are You Ready for the Best the Southeast Life Sciences Industry Has to Offer?

southeast life sciences pitchrounds

Life science and medtech investors, are you ready to meet your next opportunity?

 

Life science and medtech innovators, are you ready to meet your next investors or solution providers?

 

Life science and medtech solution providers, are you ready to meet your next clients?

 

Tech transfer colleagues, are you ready to move more of your institution’s technologies into the commercialization pathway?

 

The 2021 edition of Southeast Life Science’s flagship event, AdvanSE, is one month away. October 27 – 29 in Isle of Palms (Charleston), South Carolina, we will showcase the best of what the southeast life science ecosystem has to offer.

 

In case you missed it, we require proof of Covid vaccination to attend AdvanSE 2021 in person. 

 

Recent items of note:

 

In 2019, the Southeastern Medical Device Association (SEMDA) and Southeast BIO (SEBIO) officially merged to form Southeast Life Sciences. The merger created a single, unified platform for medtech and bioscience innovation, partnering and investor relations.

 

OUR VISION
A world-class ecosystem for life sciences in the southeast.

 

OUR MISSION
SLS cultivates, convenes, and connects the Southeast entrepreneurial ecosystem to foster life science innovation & investment across the region for the greater good.

 

We can’t wait to see you next month!

 

Jason

Pulling research out of higher ed and into a high potential commercial pathway: Q&A with Bayer’s Hanna Eilken

No matter the brilliance of the research, or researcher, life science innovation relies on a rigorous regulatory and commercialization pathway before its potential to improve lives can enter patient care, at almost any scale.

 

Universities rely on their technology transfer offices and commercial entities like Bayer to pull high potential research and technologies out of the academic or research environment into clinical utility.

 

Dr. Hanna Eilken, strategic alliance manager with Bayer, provides insights into her organization’s red flags, processes, requirements and what she wishes more researchers knew about Bayer’s methodology for pulling research out of a university setting and into your commercialization pathway in the following Q&A. 

 

Enjoy!

 

  • What attracts you to research coming out of a higher education setting?

 

Drug discovery and development becomes increasingly challenging with long development times, increasing costs, growing competition, and insufficient predictability of translation of preclinical data. Thus, engaging with universities and associated research institutions, to join forces and complement competencies is an important pillar to drive innovation in pharmaceutical companies. Academic research provides access to scientific excellence, disruptive technologies and cutting-edge approaches that are a source of creative solutions which are required to successfully develop effective treatment options, and to bring innovation to patients. 

 

Bayer has recognized that complementing its in-house expertise with the know-how of academic scientists is mutually beneficial for both partners. We set up and execute co-operations in a collaborative fashion with shared risks and rewards. For example, Bayer has established the Joint Precision Cardiology Lab with the Broad Institute of MIT and Harvard which aims to combine Broad’s innovative methods for basic science discovery such as single cell sequencing and clinical expertise, with Bayer’s long experience in drug development to discover new potential therapeutics in cardiovascular diseases. Thus, we combine our expertise to jointly enable the development of new therapies for patients with cardiovascular diseases such as heart failure.

 

  • What are the top red flags when engaging with academic institutions?

 

Usually, scientists in a university setting have the same motivation as pharmaceutical companies: bringing innovative therapeutics to patients. However, bringing together academia and industry also means – for both parties – accepting different cultures, mindsets and approaches. Often, both partners have the same goals but different ways of achieving them. A red flag would be to not: be open for new ideas, willingness to adapt, constant alignment, collaboration and personal interaction on the scientist and leadership level. From my perspective, it is very important to invest time to understand each other and build a healthy relationship. 

 

  • Where do your interactions begin and how do they progress especially regarding the people and what you need from them? 

 

Interactions begin through various channels, e.g. through Bayer scientists, BD&L, Open Innovation and Leaps teams who are pro-actively scouting for technologies, assets and expertise that synergize with our in-house activities. In addition, we are often approached by academic researchers who wish to discuss their innovation with Bayer. We ask them to present their data and invite them to jointly discuss opportunities and potential challenges of the technology in non-confidential conversations. In the event there is mutual interest, we align on details of how a collaboration should look like and what partnership model we would pursue. 

 

  • At what point do you closely examine IP and what do you require to proceed?

 

Patent protection is a prerequisite for drug development in a company like Bayer, and it is essential that the patent term is sufficiently long after commercialization. We review the prospective patent portfolio early in the due diligence process. 

 

  • What do you wish more tech transfer officers knew about your methodology for pulling research out of a university setting and into your commercialization pathway? What do you wish more researchers in higher education knew about what’s needed to successfully transfer their work into a commercialization pipeline? 

 

While many scientists do have a basic understanding of the drug development process, it is important to understand how they need to tailor their program towards commercialization. Talking to investors, big pharma or other potential partners can help to resolve some of the open questions and better understand how these potential partners are thinking. Many Tech Transfer Offices possess a solid understanding of what big pharma is looking for and they work with their investigators to identify gaps and shape a program towards commercialization. 

 

Bayer has recently launched a few programs which are tailored to bring innovators from academia and young start-ups closer to big pharma, for example mentoring programs, Bayer-Access and the Center for Regulatory Excellence. In the Bayer Access program, Bayer offers expert guidance from multiple business and scientific perspectives, e.g. preclinical pharmacology, data science, drug discovery sciences, formulation and BD&L, and we jointly mentor the scientists, providing expertise and recommendations in a 1:1 session. 

 

The Center for Regulatory Excellence is a novel initiative by Bayer and MassBio enabling academic scientists and young start-ups to learn from regulatory experts. We offer Think-Tank, educational sessions where we share our knowledge, expertise and experience when working with the FDA and other regulatory authorities. In addition, innovators can also apply for a selective 1:1 mentoring session with Bayer regulatory experts to discuss their project-specific questions.

 

In depth conversations as described above are extremely valuable for scientists and help to understand the complexity of the drug development process.

 

AdvanSE 2021 is fast approaching! Will you join us?

Southeast Life Sciences thanks Hanna for sharing her insights with us. Come see the best of what the southeastern U.S. life science ecosystem has to offer at the 2021 edition of our flagship event, AdvanSE, October 27 – 29 in Charleston, SC. 

On “Optionality,” Exits and Giving Science the Best Chance to Save Lives

A Southeast Life Sciences Q&A with AskBio Co-Founder and CEO Sheila Mikhail

 

“The field of gene therapy was in a nuclear winter in 2001,” said AskBio Co-Founder and CEO Sheila Mikhail. 

 

Motivated by belief in the science of gene therapy in order to give the blind a chance to see or give more children a chance to live full, healthy lives, AskBio used creative financing, grants and selective scientific technology sales (or exits) to keep its vision and work alive. It would be more than 15 years later that the company took on its first round of funding, $235 million.

 

In October 2020, Bayer acquired AskBio in a deal worth up to $4 billion including potential milestones. As reported by BioSpace, “Under terms of the deal, Bayer will own full rights to AskBio’s pipeline of treatments for Pompe disease, Parkinson’s disease, as well as therapies for neuromuscular, central nervous system, cardiovascular and metabolic diseases.”

 

The AskBio team does a much better job telling their story and explaining their science than we ever could. We encourage you to read the pioneering story of Jude Samulski story as published on their website.

 

What we at Southeast Life Sciences want to share with this community are Sheila’s insights into what mature, late stage life science “startups” need to know when an IPO or exit to a large “strategic” like Bayer looks like it could be the next milestone in the company’s journey. 

 

Sheila graciously shared her insights with Paul Snyder, VP of Healthcare for Write2Market. We hope you find these insights in the Q&A below informative and useful.

 

Q: How long had potential acquirers been looking closely at AskBio?

 

A: “We had long standing connections with large life science companies through collaboration or colleagues. Pfizer’s acquisition of Bamboo Therapeutics was a significant moment for us, and for gene therapy’s maturation into a new pillar of medicine.”

 

Editor’s note: Bamboo is an AskBio spinout focused on gene therapies for four severe diseases: 

 

  • Giant axonal neuropathy, a disorder of neurofilaments, the structural framework that helps define the shape and size of nerve cells.
  • Friedreich’s ataxia, a progressive degeneration of nervous tissue in the spinal cord.
  • Canavan’s disease, a progressive deterioration of nerve cells in the brains of infants.
  • Duchenne muscular dystrophy, a progressive degeneration of muscles.

 

“We realized in 2020 that we had to take more cash for the tools we needed to address the myriad varieties of complex diseases with the synergy of small molecules and gene therapy. Things heated up at JPMorgan 2020 because acquiring our technology and pipeline was almost certainly going to have a higher ROI before an IPO than after.”

 

Q: What can other innovators, including those that look like AskBio just prior to 2020, learn from your experience as Bayer closed in on acquisition?

 

A: “Investment bankers talk a lot about ‘optionality.’ It’s a key driver of transaction completion. You are more attractive with multiple options available like an IPO, multiple bidders, the ability to continue to go it alone if needed, or investors willing to put more money into the company.

 

“If you’re backed into a corner, desperately seeking an exit partner or seven-figure or greater investment, the transaction probably won’t happen. But if you do find yourself in a corner, learn how to bluff really well and never let them see you sweat.”

 

Q: What, if anything, do you wish you had known before?

 

A: “I wish I’d had a better idea of just how hard it would be. I kept thinking I might have been making a mistake, that I wasn’t experienced enough, that I wasn’t good or capable enough. But I believed in the technology’s life saving potential and had to give these transformative therapeutics a chance to make lives so much better.”

 

Q: What advice would you give aspiring women in life sciences, including students at almost any level or clinician innovators with ‘an idea?’

 

A: “Try to not spend time worrying about other people’s opinions. You will find yourself alone more often than you might like. Continue to advance your science, your therapies. Get them to the clinicians, watch the impact and keep your eyes on the objective. Be true to who you are and do the best you can by the science, by the patients, by the employees and by the science and technology.”

 

Southeast Life Sciences thanks Sheila for sharing her insights with us. We hope to see you at the 2021 edition of our flagship event, AdvanSE, October 27 – 29 in Charleston, SC.

Life Science Investors, Find Your Next Investable Opportunity and Network with Your Peers at AdvanSE 2021

Registration for the Charleston event, October 27-29, 2001 is free for qualified investors

 

Life science investors, the 2021 edition of Southeast Life Science’s flagship conference, AdvanSE, is fast approaching. It is Oct. 27-29 at the Wild Dunes Resort outside of Charleston, SC. In case you are unaware, Southeast Life Sciences was formed in 2019 from the merger of Southeast BIO and the Southeastern Medical Device Association. 

 

The AdvanSE conference is the premier regional conference for life science innovation. Over the course of its history this event has contributed to 790 funding transactions and $6.2 billion raised through 500 distinct investors.

 

We are building levels of investor and partnering opportunities you might experience at leading national events hosted by BIO and Advamed. AdvanSE is the place to find your next, de-risked investable opportunity in the life sciences.

 

Peer-to-peer events exclusively for investors

This year we are planning networking events exclusively for investors and large corporate attendees to ensure that you get the best experience possible. We believe this is one of the best reasons to attend. These events include: 

  • Oct. 27 morning: Golf available on the morning of October 27
  • Oct. 27 morning: SE Surge, an invitation-only event designed for large corporate attendees and research universities in the southeast. Investors are invited. 
  • Oct. 27 afternoon: Boat tour of the Charleston harbor with investors and corporate attendees 
  • Oct. 27 evening: Cocktail reception with investors and corporate attendees
  • Oct. 27 evening: Dinner with investors and corporate attendees (featuring a low-country boil)

 

We have the ecosystem’s health and safety front of mind for AdvanSE 2021

Last month we announced that all attendees and staff are required to be fully vaccinated* to attend the event. We determined that the AdvanSE Conference can be the most robust, productive and interactive conference possible by requiring vaccinations for entry. We have not made a decision on masks or available on-site testing, but we will continue to update our safety requirements. 

 

The advantage to investing in innovative southeast life science companies

The Southeast United States has all of the resources needed for, and a proven track record of, life science innovation from its infancy through development, testing, regulatory submission, entry to patient care, growth — and in some cases very high value acquisitions.

 

The Southeastern United States has the technical talent, clinicians, patients, connectors, collaborators, quality of life and lifestyle that creates a critical mass for efficient life science innovation and commercialization.

 

Registration is free for qualified life science investors

If you have any questions, or would like to request gratis registration as a qualified investor, please contact me via email: jrupp@southeastlifesciences.org

The Frontier of Precision Based Behavioral Health: SE Color Winner Spotlight: Polaris Genomics

Improving the antiquated,  inadequate “Gold Standard” for PTSD diagnosis and treatment

 

Charles Cathlin wanted to be a pilot. With a sister serving in the U.S. Air Force and a predisposition for science and technology, Colorado Springs was calling. But…

 

“It seemed like everyone knew I was color blind except me,” he said. 

 

Nevertheless, Charles served six years in the Air Force as a bioenvironmental engineer working to mitigate or eliminate environmental hazards in industrial arenas like aircraft maintenance facilities. After deployments to Albania, Mozambique and the Middle East, Charles joined the United States Public Health Service Corps’ division on emergency response and preparedness in August 2001. His department was responsible for the medical response to the terror attacks on New York and Virginia the very next month.

 

“We knew how to protect first responders and uniformed service members from the myriad environmental hazards they faced in response to the events of September 2001,” Charles said. “But there was no protection at all from the mental health impacts responders inevitably faced.”

 

In 2016, he learned of pioneering PTSD biomarkers and genomics research conducted by Dr. Rachel Yehuda at the Icahn School of Medicine at Mt. Sinai in conjunction with Dr. Florian Holsboer at the Max Planck Institute.

 

An aging, inadequate “Gold Standard” for PTSD diagnosis

The current gold standard for PTSD diagnosis is a self-reporting survey, Charles stated in his winning pitch to the Southeast Life Sciences 2021 SE Color panel. Bias, stigma and the variety of symptoms are just three challenges to diagnosing PTSD. Currently, there are 22 veteran suicides daily.

 

“The current system lets people fall off the cliff while the ambulance waits at the bottom,” Charles said. “We’re building guardrails to intervene ahead of the tragic outcomes that come from undiagnosed, untreated behavioral health disorders.”

 

Charles co-founded Maryland-based Polaris Genomics to identify earlier and more effectively diagnose and treat mental health disorders. Polaris licensed the PTSD biomarker patent from Mt. Sinai and expanded its capability from 3 genes to more than 1,000 with correlating mental health conditions. The team then built the TruNorth Platform, a bioinformatics engine to ingest genomic information, analyze it and apply AI for predictive modeling and reporting for clinical use.

 

Editor’s note: At the end of his service with USPHS, Charles spent 10 years at the FDA including serving as the Chief of Neurology and Radiology Devices.

 

The frontier of precision based behavioral health 

Polaris is a veteran-owned business that remains committed to its founding mission of improving the lives of U.S. military service members and veterans living with behavioral health conditions such as PTSD. Over the last 18 months, an evolving behavioral health landscape amid the Covid-19 pandemic highlighted the urgency for advances in diagnostics and treatment for many more populations. Answering a calling to serve, Polaris officially launches with an expanded mission addressing:

 

  • Veterans and active-duty US military service members,
  • First responders, frontline workers, and individuals in high-risk occupations, and
  • Trauma-exposed communities at large.

Building on research into the biological basis of PTSD and other neuropsychiatric conditions, the team at Polaris is working to develop the frontier of precision behavioral health with the first objective and evidence-based diagnostics and therapeutics.

 

“Experiencing PTSD is not exclusive to veterans,” Charles said. “Just look at the hand that healthcare workers and first responders have been dealt in dealing with Covid-19 and the mental health repercussions they will continue to face in the foreseeable future.”

 

As of this publication date, Polaris is completing validation on a clinical product in partnership with Sanford Health, while laying out a Series A funding strategy for an early 2022 push. 

 

Charles Cathlin

“We have goals set for science and product development, finance fundraising, team building, marketing and business development,” Charles said. “We want to form a company with the right people. Failing to do so can cause a lot of chaos with the wrong people in roles necessary to move the company forward. We spend a great deal of time on team building and development because we know how important it is to get it right.”

 

“Scientifically, unlike cancer, you can’t see or biopsy within mental health conditions. We’re doing some of the work needed to identify the biological underpinnings of those conditions with validation and research partners at Sanford Health and Defense Research and Development Canada.”

 

In addition to the fundraising plan mentioned previously, Polaris’s marketing and business development efforts center around gathering as much input from their network, including KOLs, as possible to position the technology for successful commercialization.

 

Finding the right, ripe markets for early commercialization, while building a path to providers

“Commercialization is a top area of focus at the moment,” Charles said. “We are talking to potential customers for feedback and input. There are some interesting therapeutic products being developed by the pharmaceutical companies. But identifying patients for clinical trials is proving difficult for them. Adding a genomic component to the PTSD diagnosis pathway could provide a significant boost for their recruitment efforts.”

 

“The provider community in the PTSD arena will be slower to adopt this technology,” Charles said. “Shifting from self-reported surveys, observation and conversation to utilization of genomic, bioinformatic data and AI will be a heavy lift in the clinical community. The research market and potential pharmaceutical market will support our work while we continue to educate clinicians.”

 

We applaud Charles and his team’s noble, novel approach to an unmet need that may well save thousands of lives and improve the lives of millions more that suffer PTSD. From their own story, “The team has garnered numerous awards, ranks, titles, and accomplishments, ranging from captain to engineer, Purple Heart recipient to medical doctor, virologist and immunologist, 9/11 responder to Iraq War veteran, and PhD to Homeland Security Public Health Officer amid the threats of SARS and anthrax.”

 

Watch Charles’s winning pitch here.

 

About Southeast Life Sciences

Southeast Life Sciences cultivates, convenes, and connects the Southeast entrepreneurial ecosystem to foster life science innovation & investment across the region for the greater good.

 

We’re the network that brings all southern life science innovation together in one place: for investors, we bring your next investable opportunity; for young companies, we introduce you to your investors and potential partners; universities & corporations, move your research or innovation into the commercialization pathway; for solution providers, we bring your next clients.

 

We are the proud creator and producer of the AdvanSE Life Sciences Conference, an annual gathering of the most innovative life sciences companies, researchers and discriminating, accomplished investors and corporations that want to do business with them. 

 

The 2021 AdvanSE Life Science Conference, Southeast Life Science’s flagship event, will be October 27-29, 2020 in Charleston, SC. 

 

In 48 hours at AdvanSE, investors can see the very best of what the southeast life sciences innovation ecosystem has to offer.

 

Register.

Taking shape: A look at the breakout sessions at AdvanSE 2021

Southeast Life Science’s flagship event, AdvanSE, is fast approaching; October 27-29, 2021 in Charleston, SC. Every year, it presents a powerful opportunity for life science innovators and entrepreneurs to showcase their companies to an audience of discriminating investors.

The 2021 program is taking shape. Below are the breakout sessions confirmed to date. 

Here to stay: how hybrid engagements accelerate innovation for med affairs and commercial teams. As teams adapt to a post-Covid world, how can virtual engagement increase its value provision to medical affairs and commercial teams further accelerating commercialization? What strategies and tools should leadership of life science companies embrace as a hybrid approach to medical affairs and commercial programs becomes the norm and starts to mature? Sponsored by Write2Market

Diagnostic: Moving to the forefront of Global Healthcare. The COVID virus has demonstrated the incredible power of molecular diagnostics, and global informatics, to track constantly-mutating infectious diseases, and to accelerate development of a new arsenal of vaccines and therapeutics.  This panel will discuss some of the trends, innovators, and future directions for investments that help bring about the long awaited promise of “personalized medicine.”

MRNA: Transformational technology. mRNA has become a widely-known term after Moderna and Pfizer developed vaccines using the technology, but there is much more potential than that. This panel will cover the background on how the vaccines were created so quickly using MRNA and examine the potential of the technology in the future.

FDA update. The pandemic created a situation where the FDA needed to move more quickly than any time in its history. This panel will cover what the FDA did to move quickly on covid-related products, while exploring what long-term changes might result from the successes. Sponsored by MRC Global 

Business Opportunities for Small Companies in Telemedicine. Telemedicine took a dramatic leap forward during the pandemic, going from a tool to an integral part of the entire process. This panel will discuss these changes and the implications for topics such as clinical research, precision medicine, pharmacogenomics, and orphan disease treatment. 

AI and Applications in Life Sciences. The FDA has put out guidance on how to put together change management and specific protocols to help companies using AI. This panel will discuss topics as the next frontier in AI – apps that – and the convergence between industries in healthcare. The panel will also look at the trends in investment – where is money being deployed and what technologies are receiving new investment as a result of covid. 

Judo and Life Science Investing. The Smart Money in Life Science Investing is Smart Everywhere, In Every Phase Including the Supply Chain and Manufacturing. The Pandemic taught us that “just in time” and “lean” processes are easily and thoroughly disrupted when multiple environmental changes take place. How do you reduce that risk? Make sure your team has the right expertise in manufacturing and supply chain then learn to play Judo with suppliers.

Successful Implementation of Remote Working Models. This interactive panel and discussion will cover the increasingly prevalent “virtual” work environment and how it may positively impact life science companies. Leveraging national and international resources is more viable now than ever, and can be a more efficient way to accelerate business growth. We will explore models and implementation strategies for remote and fractional executive management, as well as preclinical and clinical research.

Stay tuned for keynote updates as we confirm them.

Southeast Life mission is to cultivate, convene, and connect the Southeast entrepreneurial ecosystem to foster life science innovation & investment across the region for the greater good. We facilitate connections, conversations and capital investments through continuous networking, education and funding opportunities for life-science innovators of all shapes and sizes.

Note: After careful consideration and consultation with internal and external health and safety experts, Southeast Life Sciences has decided to require all attendees and staff to be fully vaccinated* to attend the event. We determined that the AdvanSE Conference can be the most robust, productive, and interactive conference possible by requiring vaccinations for entry.

Learn more.

Five reasons you can’t afford to miss the 2021 AdvanSE Conference

southeast life sciences pitchrounds

The opportunity to attend the premier event for life science professionals in the Southeast is on for October 27-29 in Charleston, SC! 

Here are five reasons you should attend:

Networking.

The SEBIO and SEMDA Conferences were always highly rated by attendees for value, information, and logistics, but the item that receives the most attention is the excellent networking that occurs throughout the conference. After nearly two years of few in-person events, we are preparing the best networking opportunities available. We will host receptions for both SE Color and Women@SLS, have two high-quality receptions on Wednesday and Thursday, and a (tentative) reception on Friday, so there will be plenty of time to connect with old friends and colleagues and make new connections. 

1:1 Partnering.

SE Connect, the one-on-one partnering system at the AdvanSE Conference, is one of our most popular features. Throughout the two days of the conference, we expect to host hundreds of meetings. Even if you register for the virtual event, SE Connect facilitates live partnering, so you’ll get the same experience. We’ll launch the app well ahead of the conference, so the sooner you sign up, the better your chances of scheduling time with the people and companies you want to meet!

Presenting Companies.

The AdvanSE Conference is the premier regional event for life science innovation. We expect to host the top companies in the region for presentations that are open to everyone on October 28. Later-stage companies will present during breakout sessions later in the day. 

Keynote Speakers & Panels, and More.

There’s so much going on at this year’s conference that you’ll be hard-pressed to take it all in. Our keynotes include a presentation from Silicon Valley Bank on the investment landscape in the region, top investors speaking to the SVB data and how it compares to “on the ground,” a former Walmart executive, and more.  

Education Programming. 

With more than dozen breakout sessions, there’s sure to be a topic that will enhance your knowledge and provide lasting value. Although there is no theme for the conference, many of our sessions will explore a post-covid world from the perspectives of the FDA, Artificial Intelligence, Telehealth, and more! Plus, we will have presentations for Women@SLS and SE Color. Visit the main event page for more information.