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.
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 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 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.
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.
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 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 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.
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.
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.
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.
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.
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 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.
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 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 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 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 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.
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.
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.