PitchRounds Alumni Acclinate and Embody Close New Funding Rounds

According to industry sources and confirmed by Crunchbase, PR Newswire and Silverwood Partners, two PitchRounds at Southeast Life Sciences (or SEMDA) alumni recently raised seven and eight figure funding rounds.

Acclinate, a PitchRounds 2020 presenting company, raised $4.9 million for its endeavors to achieve diversity in clinical trials, while Embody, a two-time PitchRounds presenting company (2018 and 2020) raised $10.4 million.

Jeff Conroy, Founder & CEO, Embody (Image credit: Embody)


From PR Newswire, “Embody, Inc., a privately-held medical device company focused on soft tissue healing, announced today that it closed a $10.4 million Series C funding round led by Genesis Innovation Group’s cultivate(MD) Capital Funds LP. The financing will enable Embody to expand its world-class operations, post-market clinical studies of the recently launched Tapestry RC System for rotator cuff and prepare for the commercial launch of ActivBraid™ high-strength collagen-based suture technology in 2023.

“This financing represents a notable step in the continued growth of Embody,” said Jeff Conroy, Embody’s Founder and Chief Executive Officer. “We are thrilled to have the continued support of our highly seasoned investor base, further illustrating the opportunity and need of our soft tissue healing technology portfolio.”

Acclinate, Silverwood Partners briefly reported, …raised $4.9 million of venture funding from undisclosed investors on October 19, 2022. The company is a developer of a digital health analytics platform designed to assist biopharmaceutical research organizations in increasing the representation and diversity of their genomic research and clinical trials.”

Crunchbase’s profile of Acclinate appears to confirm the recent transaction.

Scott McCarty

“One of Southeast Life Science’s core missions is to introduce investors, including large strategic enterprises that frequently innovate through acquisition, to their next investable opportunities,” said SLS Co-Chair and Silicon Valley Bank Director Scott McCarty. “While we certainly can’t take too much credit for these funding rounds, we are always proud to see PitchRounds presenting companies follow on their participation with funding rounds like these.

“The southeastern United States has all of the elements needed for high value life science innovation and investment.”

In It for the Long Haul: The story of Nephrodite’s quest to radically transform care for kidney failure and dialysis patients.

When deep seated, long-unmet clinical needs for a very large patient population meet one particular young patient’s journey, opportunity for innovation knocks. Loudly.

“All Holly wanted was to be ‘normal,’” said Nephrodite Co-Founder and Urologic oncologist Nikhil Shah, DO, MPH. “After years of living in fear, in constant sickness, full of stress, constantly in and out of dialysis centers, she did at last receive a kidney transplant. Ultimately the transplant failed and she succumbed to kidney failure.”

In the 1940s and 50s, pioneering dialysis technology extended the lives of patients with renal disease and kidney failure, previously a veritable death sentence. That technology has changed little in the past seven decades or more.

“Advancements in technologies for other high volume, high impact diseases like heart disease and heart failure, like LVAD [left ventricular assist devices], have improved the lives and outcomes by leaps and bounds in the past 10 years,” Dr. Shah said. “It is past time for new technologies to do the same for millions of patients who rely on dialysis for their very lives.”

Nephrodite co-founder and Pediatric Urologist Hiep Nguyen, MD, specializes in surgical advances in kidney disease and urinary reconstruction, including kidney transplantation. Almost 10 years ago, Drs. Shah and Nguyn set out to create a technology “to restore freedom, function and independence to individuals with end stage kidney disease.” 

Enter Holly(™), a continuously functioning dialysis device, one of only a few technolgies in the artificial kidney space to ever be developed. the nearest technology to an artificial kidney ever developed.

Given Holly’s potential impact across its patient population to improve outcomes and reduce cost for a disease with very high priorities for global health organizations, and very high investability potential, Nephrodite earned the winner’s position in the PitchRounds at AdvanSE 2022 device category in May of this year.

 

COMMITMENT

As a U.S. FDA Class III technology, Holly’s commercialization pathway is the most rigorous, time consuming and costly in the medtech innovation discipline. It is not unreasonable to assume total concept-to-commercialization costs for Class III devices to approach, or exceed $100 million.

“Our work started many years ago; trying to miniaturize a common, quite large dialysis machine to about the size of a small child’s fist, implantable in humans,” Dr. Shah said. “It has been no small task, but we have ensured our technology is sound and all these years later now have a functional prototype. 

“We have had many opportunities to walk away, which I suppose is not uncommon for an implantable technology that requires PMA (premarket authorization) as an FDA Class III device.

“But we have done a tremendous amount of de-risking, we have close ties to the unmet need, the patient population and the technology itself. Our team is dedicated, passionate and we intend to see this technology all the way through to commercialization.

“We are, without question, in it for the long haul.”

Current status

Nephrodite relocated its headquarters to Atlanta earlier this year where it entered into Georgia Tech’s Advanced Technology Development Center.

“We relocated to Atlanta in order to leverage the abundance of talent and resources not just in Atlanta, Georgia but in the Southeast,” Dr. Shah said. “But we were not aware at the time of just how robust the life science ecosystem is including the ATDC, Georgia Bio, SEMDA – now Southeast Life Sciences – and supporting entities like the Global Center for Medical Innovation on top of all the scientists, clinicians, regulatory experts and others. 

“We have been working to both make our presence known and avail ourselves of the local and regional assets and resources, which are plentiful.”

Nephrodite has recently accepted an invitation to be part of the Center for Medtech Excellence, which “will provide a reimagined, comprehensive approach for concept to commercialization and sustainable innovation, which is crucial for cultivating more agile healthcare organizations. Georgia Tech will develop the Center for MedTech Excellence – a three-year collaboration with the Advanced Technology Development Center (ATDC), the Georgia Manufacturing Extension Partnership (GaMEP), and the Global Center for Medical Innovation (GCMI).”

What’s next

In addition to its recent FDA application for a breakthrough technology designation, the company intends to raise Series A funding starting in Q2 2023 to complete development of a clinically appropriate, human-ready device in order to then initiate requisite preclinical testing in chronic models sometime in 2024. (Prospective, interested investors should contact Nikhil Shah, nshah@nephrodite.com).

“In the very near-term, we intend to raise awareness for our cause and its associated burden, in addition to forming a community advisory board for those on dialysis or those passionate about kidney disease to improve treatment options, outcomes and lives for patients worldwide,” Dr. Shah said. “We will be seeking volunteer based input on the device’s design and functional attributes with particular attention devoted to patient-centric needs for day-to-day living with our device.

“We welcome interested parties, be they patients, care givers, family members, clinicians or members of the scientific and research communities to contact Niraj Khurana, our Director of Operation (niraj@nephrodite.com) to learn more about participating in the community advisory board.

Lessons to Learn: Engage regulators early, often and never underestimate the importance of team acumen, timing

When asked what advice he would give to other medtech innovators, Dr. Shah shared the following:

“Try to include and understand what it’s going to take [to meet] regulatory requirements, milestones and inflection points as early as possible.

“Engage the formal regulatory body early and often. They will only help you. They are much more accessible, much more understanding and supportive of innovation and innovators with more available resources to help you verify actions or assumptions than people know. 

“Telling your story in a few minutes is an art that needs development and practice. It is important to understand your audience and your value proposition for them, but do not exclude your overarching value to the larger community, to everyone ‘in the room.’

“Assemble your team, internally or otherwise, carefully. Investors do indeed look closely at team members, their acumen, accomplishments and fit for function and timing.”

Southeast Life Sciences thanks Dr. Shah for sharing his insights with us.

High Potential: A Fully Unmet Clinical Need, a Compelling Story, Compelling Science, Market and a Clear Commercial Pathway

The right stuff made Plakous Therapeutics’ technology worthy of a winning ‘biomed’ PitchRounds position at AdvanSE 2022.

 

Baby Laurel was born at 24 weeks, 5 days, more than 15 weeks premature weighing just 1.5 pounds. Laurel is one of the roughly 3,000 very premature babies born in the United States every year who develop Necrotizing Enterocolitis (NEC), a rare pediatric disease without an approved diagnostic test or treatment. Nearly one-third of those cases result in the death of the infant due in part to inadequate length of exposure to amniotic fluid in the womb.

 

In addition to the high mortality rate for NEC, the current, extensive course of treating extremely premature babies with the rare disease brings an estimated $1.75 billion in NICU costs alone every year. 

 

Common complications of NEC include neurodevelopmental delay, failure to thrive,  gastrointestinal problems including strictures and adhesions, cholestasis, short bowel syndrome with or without intestinal failure that can be difficult to manage.  

 

Scott Washburn, MD, OB/GYN, the founder and Chief Medical Officer of Plakous Therapeutics set out to develop a placenta based biotherapeutic, a cell free mixture of cytokines and growth factors that mimics second trimester amniotic fluid in 2016.

 

Fast forward to the present day and, according to Plakous, “necrotizing enterocolitis remains the most threatening gastrointestinal complication of prematurity leading to high mortality, morbidity and cost.

 

Plakous Therapeutics’ novel treatment for NEC has shown a significant reduction in the severity of the disease. In preclinical studies of animals treated with Plakous’ biotherapeutic the severity of the disease was reduced by greater than 33%. The team and technology has further achieved:

  • Orphan Drug and Rare Pediatric Disease Designations from the FDA which includes access to a priority review voucher upon BLA approval
  • Accelerated FDA review (6 months)
  • Streamlined clinical trials
  • Market exclusivity
  • NIH SBIR Fast Track Grant of $1.72M 
  • Mayo Clinic agreement to develop Natural History Study

 

An Innovation Worthy of Ecosystem Validation

“Plakous Therapeutics has a unique offering that will be reimbursed; a platform biotherapeutic to prevent the rare pediatric disease, Necrotizing Enterocolitis, a true unmet medical need with no other product available,” said Life Science Management Consultants CEO Valerie Darling. “NEC afflicts 6% of the 50,000 babies born annually in the U.S weighing less than 3 pounds and carries a 30% mortality rate, represents $8.0B in overall healthcare costs, and 20% of annual NICU expenses. The therapeutic has received rare pediatric disease and orphan drug designations from the FDA, guaranteeing reimbursement.

 

The PitchRounds at AdvanSE 2022 judges deemed Plakous’ technology and opportunity worthy of the winning position in the biotechnology category.

 

“It was difficult to choose a winner at this year’s Pitch Round Competition due to a plethora of excellent companies and game-changing innovations,” said Darling. “In the end, it came down to ‘investability’ – the company that yielded high likelihood for an expedient return on investment with a first-to-market, unique product likely to receive reimbursement for a disease state or medical condition with no other options that represented significant healthcare cost and market potential.”

 

What can other innovators learn from Plakous’ experience at AdvanSE?

“Initially, innovators tend to focus too intently on their science and not its benefits during ‘introductory’ funding pitches to prospective investors,” Plakous CEO Robert Boyce told us. “In our prep sessions with our mentor colleagues we learned that we needed to focus more highly on our product’s benefit and how that benefit, the data, gets created more intently than on the chemistry or science itself.

 

“Almost every pitch scenario will involve unique audiences with unique levels of experience, interest and professional proficiencies. Some are more interested in the science and will not go forward until they believe the science works for them. Others will accept that your science is and does what you say it is and does at the outset, but will demand that you understand your marketplace. 

 

“It is also important to understand what you don’t know, especially related to health economics, manufacturing, logistics and therapeutic areas from which you might be taking market share, which represents a threat to some in the industry.

 

“On top of several years of refining our story and pitch decks, our colleagues at Keiretsu, and mentors introduced to us through Southeast Life Sciences have helped us crystallize audience appropriate stories and our value proposition. While the patient is the ultimate consumer of the technology, the hospital is the buyer and the doctor is the distributor. Our story, like many other innovators,’ must be compelling in all three scenarios to all three audiences.”

 

Funding the home stretch to FDA IND application and first-in-human trials

As of this story’s publication date, Plakous is narrowly focused on completing its pre-IND (Investigational New Drug) submission to the U.S. FDA by the end of the calendar year. Manufacturing and release testing over the next four or five months will help ensure the package demonstrates the consistency and potency of the product. Safety and toxicity studies are planned for early 2024.

 

“The activities of the next twelve to 24 months are critical to our commercialization pathway success and exit potential,” Rob said. “We are currently seeking $10.0M to get into human studies and an additional $25.0M round to get through clinical studies and to commercialization. Simultaneously, we are onboarding two new scientists and filling gaps in quality, regulatory and clinical operations to ensure we are fully prepared for the transition from preclinical to in-human clinical phases.

 

“We have a clear pathway to success for NEC and have plans–and early data–to support additional diseases of inflammation for indications including osteoarthritis and osteoporosis.

 

The team at Southeast Life Sciences congratulates Plakous Therapeutics on their PitchRounds success at AdvanSE 2022 and will be intently watching their high potential progress.

“Investability” Leads Nephrodite and Plakous Therapeutics to PitchRounds at AdvanSE 2022 “Shootout” Wins

Southeast Life Sciences cultivates, convenes, and connects the Southeast entrepreneurial ecosystem to foster life science innovation in promising companies throughout the region from investors across the country. 

 

Our investor colleagues count on us to present to them the highest potential life science investments the southeastern United States has to offer. 

 

Thanks to the focused, dedicated work of our selection committee and judges, we proudly present the winners of PitchRounds at AdvanSE 2022 winners.

 

“I have been honored to judge what was a very tough competition as this was the best slate of early stage business presentations that I’ve seen in over 15 years of PitchRound competitions,” said Southeast Life Sciences Board Member and HealthQuest Capital Venture Partner Tom Callaway. 

 

“It was difficult to choose a winner at this year’s Pitch Round Competition due to a plethora of excellent companies and game-changing innovations,” said Valerie Darling, CEO of Life Science Management Consultants. “In the end, it came down to ‘investability’ – the company that yielded high likelihood for an expedient return on investment with a first-to-market, unique product likely to receive reimbursement for a disease state or medical condition with no other options that represented significant healthcare cost and market potential.”

 

Ultimately, the judges deemed Nephrodite and Plakous Therapeutics as the winners in their respective categories.

 

Based in Winston-Salem, NC, “Plakous Therapeutics has a unique offering that will be reimbursed; a platform biotherapeutic to prevent the rare pediatric disease, Necrotizing Enterocolitis, a true unmet medical need with no other product available,” Darling said. “NEC afflicts 6% of the 50,000 babies born annually in the U.S weighing less than 3 pounds and carries a 30% mortality rate, represents $8.0B in overall healthcare costs, and 20% of annual NICU expenses. The therapeutic has received rare pediatric disease and orphan drug designations from the FDA, guaranteeing reimbursement. The judges found Plakous to have high investment potential.

 

“Nephrodite addresses a market with very few entrants: dialysis and End Stage Renal Disease, with a unique offering, a combined implantable and wearable device, [that] could represent a change in the way End-Stage Renal Disease and dialysis care is delivered. As a kidney replacement solution, HollyTM could return independence to dialysis patients by eliminating the need for ‘in-center’ hemodialysis and reducing the immobility required for home and peritoneal dialysis. This offers mobility and independence to patients with low quality of life due to having to spend three days a week in dialysis, especially as many of these patients have difficulty accessing dialysis due to socioeconomic conditions. A true game-changer.”

 

New for the 2022 edition, Keiretsu Forum’s Mid-Atlantic and South-East regions committed to providing pitch opportunities to both regions for the winners of the PitchRounds competition. Plakous and Nephrodite will enjoy this opportunity. Historically, 80 to 90 percent of companies that are asked into due diligence at Keiretsu enter into funding agreements as well. In 2021, Keiretsu Forum Mid-Atlantic and South-East regional members invested over $13.1 M in 45 companies. In addition to the winners, co-finalists Lineus Medical and Luminelle receive admission to an upcoming Keiretsu workshop on valuation, term sheets, and due diligence.

 

“Nearly every attendee including investors from which we heard described the 2022 class of PitchRounds at AdvanSE as the strongest to date,” said Southeast Life Sciences Board Co-Chair and Silicon Valley Bank Director, Life Sciences, Scott McCarty. “Our post event attendee survey validated this sentiment. 

 

“We are grateful for the tireless work of PitchRounds Chair Russell Douglas, the PitchRounds committee members, mentors, recruiters and judges for helping us achieve our mission of presenting the finest the southeast has to offer in investable life science opportunities.”

 

2022 PitchRounds at AdvanSE Committee, Mentors & Judges

Ashley Hancock – Innovetica

Barry Etra – Keiretsu Forum Atlanta

Donna Edmonds – Brainbox

Greg Carlin – Meunier Carlin and Curfman, PA

Harry Venezia – HealthCare Capital

James Bell – Greater Bentonville Economic Develoment

Jason Rupp – Acclinate

Jeff McIntrye – Oblon, McClelland, Maier & Neustadt

Lee Burnes – Avanos

Miles Hall – Meunier Carlin and Curfman, PA

Paul Gianneschi – Hatch Medical

Russell Douglas – Verso Strategies

Scott McCarty – Silicon Valley Bank

Steven King – BioTN Mentor Network

Todd Creech – HealthQuest Capital

Tom Callaway – HealthQuest Capital

Paul Snyder – Write2Market

 

Other Judges, Mentors, Key Volunteers to the Pitch Competition

Amy Sturdivant – 58, Inc

Bill Dull – BioTech Executive

Chris Lee – Huxley Medical

David Vulcano – Music City Angels

Don Prather – Meunier Carlin and Curfman, PA

Grace Powers Powers Regulatory Consulting

Howard Lubert – Keiretsu Forum Mid-Atlantic & Southeast

Ib Badejo – Johnson & Johnson

Jim Stefansic – Cumberland Emerging Technologies

Karthik Gopalakrishnan – University of Alabama at Birmingham

Kathy Meserve – NC Biotechnology Center

Kyp Sirinakis – Epidarex Capital

Mark Samuels – TendoNova

Mathew Miessau – Epidarex Capital

Mathew White – BioTech Exec

Mike Carnes – NC Biotechnology Center

Randy Scott – HealthQuest Capital

Robert (Bob) Creeden – UVA Seed Fund & New Ventures

Russell Allen – BioTech Exec

Ryan O’Quinn – Finnegan, Henderson, Farabow, Garrett & Dunner

Tom Fagley – Hughes, Pitman & Gupton LLP

Valerie Darling – Life Sciences Management Consultants, Tings Capital

Mission, Vision, the Ecosystem and a Challenge from New Southeast Life Sciences CEO Sam Konduros

Last week, during the 2022 edition of Southeast Life Science’s flagship event and AdvanSE investor conference, Board Co-Chairs Lee Burnes and Scott McCarty formally introduced incoming CEO Sam Konduros. The organization initially announced Sam’s acceptance of the role, succeeding Executive Director Jason Rupp, earlier in May.

 

A few notes on vision, mission, the ecosystem and a challenge from Sam

 

Southeast Life Sciences CEO Sam Konduros

In addition to thanking Lee, Scott and the talented Southeast Life Sciences Board of Directors for the inspiring opportunity to serve as CEO, I’d like to recognize the visionary, dedicated work Jason Rupp, along with former board chairs Tina McKeon and Machelle Shields accomplished to create a single, powerful entity through the marriage of SE BIO and the Southeast Medical Device Association in 2019.

 

This is legacy leadership of the highest caliber. Thank you for your dedication and extraordinary service to the ecosystem and its positive impact in innumerable ways.

 

My promise to that ecosystem is that we will passionately push the envelope, guided always by the vision and mission: to build a world-class ecosystem for life sciences in the southeast, and to cultivate, convene and connect that ecosystem.

 

As the nation’s fastest growing region, the Southeast is rich in innovators and a fertile business climate positioned to advance technologies, support the creation and growth of new firms, and aggressively support strategies to on-shore life sciences companies and address global supply chain vulnerabilities laid bare by the Covid-19 pandemic. We are building our lives, careers and businesses in a 8-state region gratefully loaded with natural resources, iconic universities, innovative companies, robust healthcare systems, dynamic cities, and hospitable people with incredible diversity to celebrate, leverage and grow.

 

The region also has a strong culture and history of public-private partnerships that understand the power of real collaboration and working together. While it’s a place that is certainly not perfect, it constantly pushes for continuous improvement – and the American dream remains alive and well here.

 

We will celebrate and amplify diversity, equity and inclusion as a hallmark of our strength and culture, continually striving to set an example of excellence for the nation.

 

Southeast Life Sciences has also developed and cultivated a powerful brand. I chose to accept this opportunity because my laser-focused objective is to take a strong and fresh brand, fueled by a powerful and worthy value proposition and mission, to make Southeast Life Sciences an irresistible movement… A movement that will help catalyze the advancement and transformation of our industry – and healthcare – which needs continued reinvention in this country through the solutions our ecosystem can uniquely provide.  Our most novel ideas and promising companies will directly catalyze and contribute to the continued growth of our economy while enhancing the quality of life for all that call the region home.

 

My challenge to our partners, be they industry, government, academic institutions or affiliated life science organizations is this: If you are already engaged and supporting this movement, thank you! There are more opportunities to seize which will require more investment to unearth, foster and harvest. Bring your friends and colleagues to the party because we are stronger together. And if you’re on the edge, please reach out to us with your interests and needs if we don’t find you first.

 

Thank you to all of our partners, exhibitors, attendees, PitchRounds companies and “recruiters”, judges, mentors, and program contributors, as well as logistics and production, A/V and onsite volunteers and staff without which AdvanSE 2022 would not have been possible. The team heard from a multitude of attendees that the quality of the PitchRounds companies was exceptional in this year’s edition. Stay tuned for a post highlighting the impressive finalists and winners. 

 

Become part of this movement. 

 

To start the conversation, email Director of Marketing and Investor Relations Jared Hartzell: jhartzell@southeastlifesciences.org

 

We are now ONE Southeast Life Sciences, and by the grace of God, the future is ours to seize.

 

Let’s go!

Sam

Accelerating Early Stage Medtech: Doug Kelly, MD. U.S. Chief Scientist at FDA’s Center for Devices and Radiological Health, Thursday, May 26 at AdvanSE 2022

southeast life sciences pitchrounds

Doug Kelly, MD and U.S. FDA Chief Scientist, Center for Devices and Radiological Health, will deliver the lunch keynote on Thursday, May 26th, 2022 at Southeast Life Science’s AdvanSE 2022.  As a leader in the FDA’s transformation to integrate innovators, payors, and regulatory agencies to more rapidly enable innovators to improve patient care and lower healthcare costs, Dr. Kelly will discuss FDA’s new Total Life Cycle Advisory Program

 

Dr. Kelly  joined the FDA in 2020 after a 30-year career in the life sciences venture capital companies spanning biotech, medical devices, robotics, laboratory tools, healthcare IT, ADME/Tox simulation and clinical trial software. At CDRH, Dr.Kelly is the interface between the FDA and patient and physician groups, payors, industry, academia, innovators, investors, and other agencies and governments. His focus is on creating a more vibrant and sustainable medtech ecosystem, to bring new innovations to patients faster to relieve suffering, especially in unserved and underserved populations.

 

Douglas Kelly, MD

At his lunchtime keynote on Thursday, Dr. Kelly will present information about the new FDA’s Total Life Cycle Advisory Program (TAP) for Breakthrough-Designated products. The program combines early stakeholder input, strategic advisory services, real-time communications and radical transparency to dramatically reduce the risk, time and cost of early-stage medtech while producing more financially sustainable companies and better characterized, safer and more effective products.

 

Dr. Kelly will be our guest for his presentation, as well as participant in the conference, allowing AdvanSE company executives to explore how the FDA is working with payers and others to ensure that innovations are not only cleared by the regulatory agency, but also how to present patient-centered cost effectiveness data to provide CMS payment coverage.

 

As a former VC himself, Kelly is eager to meet with the Southeast’s top investors to see what companies are emerging and how he might help interpret the new breakthrough pathway especially around information-technology driven medical devices  including machine-learning and hospital-at-home platforms. 


Doug received his BA in Biochemistry and Cell Biology with honors from University of California, San Diego, his MD from the Albert Einstein College of Medicine, and his MBA at the Stanford University Graduate School of Business. In addition to lecturing at the Stanford GSB and Medical School, he conceived of and taught the class “Financing The Start-up,” for over a decade the Stanford’s Department of Continuing Education biggest and most popular class.


“Doug’s extensive experience on multiple sides of the life science innovation spectrum as an investor, an innovator and a regulator makes his keynote and multi-day attendance at AdvanSE 2022 reason enough in itself for those that work in the ecosystem to attend,” said Southeast Life Science Board Member and HealthQuest Capital Venture Partner Tom Callaway, MD.


If you haven’t done so, register today for our flagship event that connects innovative life sciences companies and trailblazing researchers in front of accomplished investors and corporations that want to do business with them.


In just 48 hours at AdvanSE, investors, innovators, universities and solution providers can see the very best of what the southeast life sciences innovation ecosystem has to offer. The highly efficient “shopping” of the investors, corporate partners, and companies that attend our events helps the critical mass of innovators in the region further their ingenuity through partnerships and investment.

It’s All Happening. Check out the latest program and agenda for AdvanSE 2022

Southeast Life Sciences’ flagship event, AdvanSE, brings together the best the region’s life science ecosystem has to offer. That includes networking opportunities, PitchRounds and programming that educates and informs.

 

While a bit of ‘last mile’ fluidity remains, we invite you to check out the AdvanSE 2022 agenda, curated thoughtfully thanks to the hard work of our program committee. For early, late stage and strategic innovators, for investors, for solution providers and university representatives, there is something for everyone.

 

Presenters on the agenda include representatives from:

 

Avanos,

Silicon Valley Bank,

Keiretsu Forum,

The US FDA

HealthQuest Capital,

The Global Center for Medical Innovation,

Write2Market and many more industry leaders.

 

The 2022 class of PitchRounds presenting companies is strong. Check them out for yourself.

 

Topically, strategies and tactics for accelerating commercialization, key considerations and state of affairs in supply chain and manufacturing, successful ‘marriage’ stories shared by innovators and their investors, along with spotlights on women in life sciences and SE Color represent in part our best effort to ensure the quality of content delivers value for all attendees.

 

Check out the agenda and if you haven’t done so, there is still time to register for the one-stop-shop for life science innovation in the southeastern United States.

 

Still need convincing?

 

Fact: In the past 20 years, 501 PitchRounds at AdvanSE presenting companies have raised $7.2 billion, while 70 companies subsequently executed M&A and IPO events and counting.

 

In just 48 hours at AdvanSE, investors and partners can see the very best of what the southeast life sciences innovation ecosystem has to offer. The highly efficient “shopping” of the investors, corporate partners and companies that attend help the critical mass of innovators in the region further their ingenuity through partnerships and investment.

 

Still not convinced? Consider these.

Kayla Rodriguez, MBA – Co-founder & COO, SweetBio

FROM PITCHROUNDS VETERAN & SWEETBIO CO-FOUNDER & CEO KAYLA RODRIGUEZ GRAFF

“Three weeks before the 2015 conference, SweetBio wasn’t even incorporated. Six months later, Innova and MB Venture Partners co-led a significant seed round to support FDA 510(k) clearance of our honey-incorporated advanced wound care product. From that first conference, gaining insights and feedback from Randy Scott, David Huizenga, Chris Hooper, and others helped shape our company. From investor insights to introductions to industry advisors and fellow peers, this event has us coming back year after year.”


FROM INVESTOR KYP SIRINAKIS, CO-FOUNDER & MANAGING PARTNER, EPIDAREX CAPITAL

“By attending AdvanSE, I get to meet some of the leading entrepreneurs and interesting companies in the Southeast.  AdvanSE offers exclusive opportunities to network with other investors and strategics and is the one-stop shop for innovation in the region.” Kyp Sirinakis, Co-Founder and Managing Partner,  — Epidarex Capital

 

FROM PITCHROUNDS VETERAN & INNOVATOR VANCE CLEMENT, CEO, LINEUS MEDICAL

“This conference provided us an incredible opportunity to connect with a large number of diverse life science professionals, which is not always easy to do for life science companies headquartered in the heartland. The exposure to investors and collaborators was instrumental to our early stage company.” – Vance Clement, CEO,  — Lineus Medical, Pitchrounds participant 2019 and 2021

 

FROM INVESTOR AND HEALTHQUEST CAPITAL VENTURE PARTNER TOM CALLAWAY

“HealthQuest partners are active participants in reviewing early stage businesses and investing across the healthcare spectrum – including medical devices, healthcare information technologies, diagnostics, novel delivery systems that improve patient outcomes and reduce costs. We find PitchRounds an early preview of companies that are rapidly growing and might become opportunities for investing as they seek growth capital.” – Tom Callaway, Venture Partner,  — HealthQuest Capital

AdvanSE 2022 Covid-19 Protocol

Due to the current on-going COVID-19 endemic and in light of the continued spread of the Omicron variant, The Southeast Life Sciences Executive Committee and Board of Directors has aligned on the following protocol and requirements related to Covid-19 vaccination for the upcoming AdvanSE 2022 event at the Hotel Avalon in Alpharetta, Georgia.

 

Proof of Vaccination (boosted OR un-boosted) or specific documented exemption is required to participate onsite in AdvanSE 2022. Photo evidence or hard copy proof of vaccination will suffice. We will also have ‘attestation’ forms available for those without those items to sign attesting that they have received their course of Covid-19 vaccines.

 

Masks are recommended, but not required onsite during the event.

 

We wish you safe travels and are eager to connect with you at AdvanSE.

Why attend AdvanSE 2022? Consider these testimonials.

For investors and life science entrepreneurs seeking new business opportunities, the SLS conference is one the best places to find your next de-risked investment or partnership.

 

Fact: In the past 20 years, 501 PitchRounds at AdvanSE presenting companies have raised $7.2 billion, while 70 companies subsequently executed M&A and IPO events and counting.

 

In just 48 hours at AdvanSE, investors and partners can see the very best of what the southeast life sciences innovation ecosystem has to offer. The highly efficient “shopping” of the investors, corporate partners and companies that attend help the critical mass of innovators in the region further their ingenuity through partnerships and investment.

 

Still not convinced? Consider these.

 

Kayla Rodriguez, MBA – Co-founder & COO, SweetBio

FROM PITCHROUNDS VETERAN & SWEETBIO CO-FOUNDER & CEO KAYLA RODRIGUEZ GRAFF

“Three weeks before the 2015 conference, SweetBio wasn’t even incorporated. Six months later, Innova and MB Venture Partners co-led a significant seed round to support FDA 510(k) clearance of our honey-incorporated advanced wound care product. From that first conference, gaining insights and feedback from Randy Scott, David Huizenga, Chris Hooper, and others helped shape our company. From investor insights to introductions to industry advisors and fellow peers, this event has us coming back year after year.”

 

 

 

FROM INVESTOR KYP SIRINAKIS, CO-FOUNDER & MANAGING PARTNER, EPIDAREX CAPITAL

“By attending AdvanSE, I get to meet some of the leading entrepreneurs and interesting companies in the Southeast.  AdvanSE offers exclusive opportunities to network with other investors and strategics and is the one-stop shop for innovation in the region.” Kyp Sirinakis, Co-Founder and Managing Partner,  — Epidarex Capital

 

 

 

FROM PITCHROUNDS VETERAN & INNOVATOR VANCE CLEMENT, CEO, LINEUS MEDICAL

“This conference provided us an incredible opportunity to connect with a large number of diverse life science professionals, which is not always easy to do for life science companies headquartered in the heartland. The exposure to investors and collaborators was instrumental to our early stage company.” – Vance Clement, CEO,  — Lineus Medical, Pitchrounds participant 2019 and 2021

 

 

 

Tom Callaway, Partner, HealthQuest Capital

FROM INVESTOR AND HEALTHQUEST CAPITAL VENTURE PARTNER TOM CALLAWAY

“HealthQuest partners are active participants in reviewing early stage businesses and investing across the healthcare spectrum – including medical devices, healthcare information technologies, diagnostics, novel delivery systems that improve patient outcomes and reduce costs. We find PitchRounds an early preview of companies that are rapidly growing and might become opportunities for investing as they seek growth capital.” – Tom Callaway, Venture Partner,  — HealthQuest Capital

 


Register for AdvanSE2022 today.


Recent features:

Meet the PitchRounds at AdvanSE 2022 Presenting Companies

​​Southeast Life Sciences cultivates, convenes, and connects the Southeast entrepreneurial ecosystem to foster life science innovation in promising companies throughout the region from investors across the country. 

 

Our investor colleagues count on us to present to them the highest potential life science investments the southeastern United States has to offer. 

 

“By attending AdvanSE, I get to meet some of the leading entrepreneurs and interesting companies in the Southeast.  AdvanSE offers exclusive opportunities to network with other investors and strategics and is the one-stop shop for innovation in the region.” – Kyp Sirinakis, Co-Founder and Managing Partner, Epidarex Capital

 

Thanks to the focused, dedicated work of our selection committee, we proudly share with you the roster of PitchRounds at #AdvanSE2022 presenting companies. New for the 2022 edition, Keiretsu Forum’s Mid-Atlantic and South-East regions have committed to providing pitch opportunities to both regions for the winners of the PitchRounds competition.

 

These companies represent the southeastern United States’ most promising innovative life science companies – from startups seeking milestone-based funding at six figure levels from venture capital firms, corporate venture arms, family offices, and angel groups to more mature companies with institutional investors on board seeking future rounds at $1MM to $15MM plus.

 

Editor’s note: Host hotel block room rates ($279/nt) end May 5! If you haven’t done so, make your reservation now!


Meet the PitchRounds at AdvanSE2022 Presenting Companies


Altis Biosystems, Durham, NC,
https://www.altisbiosystems.com  

Altis Biosystems is a biotechnology company that has commercialized a human stem cell platform, which accurately replicates the intestinal epithelium. It enables high-throughput compound screening and microbiome research for pharmaceutical and biotechnology companies. Our goal is to reduce the time and cost of drug discovery and reduce the need for animal testing. Altis provides contract research services and sells its platform as a kit to customers.


Annoviant, Alpharetta, GA and Greenville, SC,
www.annovianthealthcare.com  

Annoviant is on the leading edge of healthcare innovation. Our solutions are centered around addressing the unmet needs of the patient and provider. With over 150 years of combined industry experience, we develop breakthrough technologies that are designed to improve quality of life. Our team is comprised of a diverse group of professionals who share an unrelenting commitment to excellence and relentless pursuit of new ways to improve the lives of those we serve.

Annoviant’s patented TxGuard™ portfolio of decellularized tissue-based scaffolds are used in a wide range of tissue repair applications and significantly reduces healthcare costs while improving patient outcomes by eliminating the need for repeat surgeries.


APIE Therapeutics, Raleigh-Durham, NC
http://www.apie-therapeutics.com/ 

APIE Therapeutics is a start-up BioPharma pioneering an anti-fibrotic small molecule platform.  APIE has a portfolio of novel compounds that selectively target APJ G-coupled receptor signaling pathway to promote repair and regeneration of the vascular endothelium niche, precursor of many chronic and fibrotic diseases.  APIE entered an exclusive worldwide rights license agreement with well-known Research Triangle Institute of highly potent and selective Apelin/APJ agonists. APIE’s initial APT101 clinical candidate is being develop for Systemic Scleroderma (SSc), a rare autoimmune disease  characterized by vascular endothelium alterations in single or multi-organ that leads to fibrosis and organ failure. APT101 has demonstrated significant therapeutic effect in lung fibrosis, which is the major cause of early death in SSc patients.  Moreover, APT101 has the potential to address multi-organ SSc disease progression to change the disease course and survival of SSc patients.  APIE Management Team have come together in pursue of bringing innovative treatments to patients in need.


Aravis BioTech, Clemson, SC
https://www.aravisbiotech.com 

Aravis develops orthopedic devices with integrated X-ray Visualized Implanted Sensors (X-VIS) which help physicians manage fracture care and avoid catastrophic complications by quantitatively tracking fracture healing and detecting local infection biomarkers.


Cambium Medical Technologies, Atlanta, GA http://www.cambiumbio.com/  

Dry eye (keratoconjunctivitis sicca) is the #1 disease in eye care. Approximately 30M in the US have been diagnosed with the disease. There is no cure. All therapeutics today focus on symptoms relief. Most not well. Why? Most contain single drugs targeting single causes/consequences of the disease. Dry eye however is not single, or simple. Dry eye is a complex multi-factorial disease with multiple etiologies. Take-away? The need/opportunity for safe, better tolerated, more efficacious therapeutics, especially among chronic patients—remains high. Cambium’s Elate Ocular® biologic demonstrated exceptional safety, tolerability and symptoms relief among severe dry eye patients in a Phase I/II study. Cambium has regulatory approval to start Phase III studies on Elate Ocular® to begin following close of a $20M Series B financing. Cambium is attending AdvanSE 2022 to attract Series B investors. Finally, as is common in eye care, an investor exit is anticipated following studies completion.

 

Caretaker Medical, Charlottesville, VA https://caretakermedical.net 

Caretaker Medical has developed the World’s Only FDA-Cleared Wireless Wearable patient monitor for Continuous “Beat by Beat” Non-Invasive Blood Pressure (“CNIBP”), Cardiac Output, Stroke Volume, and advanced Hemodynamics parameters. Using Patented Pulse WaveForm Analysis AI and algorithms, the VitalStream™ Finger-Sensor wirelessly measures realtime patient hemodynamic information for display on our tablet app, secure internet cloud portal, and OEM monitoring platforms. Purpose built for wireless, ICU-grade remote patient monitoring free of invasive catheters, wires, and electrodes; the VitalStream® monitor is an non-invasive alternative to traditional invasive arterial catheters in ICU and surgery centers and eliminates dangerous “Blind Spots” between intermittent “spot-check” vital sign monitors at all points of care while untethering patients from bedside monitors for full mobility monitoring. VitalStream® also provides remote/home patient monitoring with the simplicity of a preconfigured tablet, streaming data to secure web portals where data analytics may ultimately provide predictive health warnings.

DeoBioSciences, Atlanta, GA https://www.deobiosciences.com/  

DeoBioSciences is a preclinical/startup stage biotech developing a therapeutic biologic for a broad range of advanced/metastatic carcinoma types in people and their pets. DBX-31 is based on a naturally sourced compound, identified and discovered through bioprospecting leads. It is being reverse engineered into a commercially viable form for clinical evaluation based on anecdotal reports and corroborating studies involving probable molecular analogues. So far, preclinical studies, conducted at Cornell University, have corroborated and met all predictions for safety and performance. Specifically, we induced high index apoptosis in 100% of advanced stage cancer cell lines that we tested, via receptor-mediated apoptosis, including some of the toughest, most treatment resistant cancer profiles known to science – without harming normal cells. We are seeking capital to test DBX-31 in patient-derived xenograft (PDX) mice models. PDX models mimic biological activity in humans and predict clinical performance with 90% to 99% predictive reliability.


Diatech Diabetes, Memphis, TN
 


GlycoPath, Charleston, SC
https://glycopath.com 

GlycoPath is an early stage biotech company dedicated to developing and commercializing new approaches to diagnose and prevent the recurrence of cancer and infectious diseases by exploiting its unique mass spectrometry imaging platform technology. The proprietary GlycoTyper is designed to classify how the glycans, or sugar code on proteins, change during the development of cancer. For decades, the role of glycans and glycoproteins have been evaluated in cancer. Through extensive studies focused on elucidating the biological functions of glycosylation, researchers have been able to implicate alterations in these functions to tumor formation and metastasis. Although this has been studied for many years, the clinical relevance of these studies has been limited due to a lack of clinical assays. The GlycoTyper assay was developed to directly address the need for a more high-throughput method for protein-specific glycan analysis from biological samples.


Heartbeat Technologies, Charleston, SC
https://www.heartbeattechsc.com/ 

Heartbeat Technologies was founded by surgeons at the Medical University of South Carolina to improve the dismal patient outcomes from cardiac arrest (90% fatal). Heartbeat Technologies developed the SAVER, a patent-protected CPR adjunct that improves blood flow to the heart and brain while providing real-time feedback on the quality of chest compressions. The SAVER can be used by healthcare professionals and civilians alike and will be stocked/sold wherever you find AEDs currently.


InfraredRX, Athens, GA
http://infraredrx.com 

InfraredRx, Inc. is a biotechnology start-up that develops non-invasive wearables and software that assess mitochondrial health and function. We have developed a suite of diagnostic tests that can bring great value to patients, healthcare providers, researchers, and insurance companies. Our mission is to help people live healthier and more active lives by providing them with accessible tools that help evaluate muscle health.


Innatrix, Durham, NC
https://www.innatrix.com 

Innatrix is committed to developing long term eco-friendly biological products to control untreatable crop pathogens, by using patented protein evolution and RNAi technologies. We are building a peptide platform, allowing the development of different spraying and seed treatment products against a broad range of crop damaging pathogens, pests, and weeds. Our first applications will be peptide products to control soybean cyst nematode, late blight and citrus greening, each of which is causing at least $1 billion losses for their crops.


InpharmD, Atlanta, GA
https://inpharmd.com/our_story 

Doctors ask drug questions. We use AI with pharmacists in the loop to respond with custom, evidence based information, so they can make better treatment decisions.


InSoma Bio, Durham, NC
https://insomabio.com 

InSoma Bio is striving to build breast implants, personalized lumpectomy molds, and repair other soft tissue defects using a person’s own tissue without the need for major reconstructive surgery. To do this, we have developed an injectable gel that allows plastic surgeons to reliably build new tissue using a patient’s own fat. We have inspiring efficacy data coupled with a substantially de-risked safety profile guiding us to the next stages of company and product development. We are raising capital to drive us through our first-in-human clinical trials, a key value inflection point for partnerships that also opens up platform use of our developing suite of products.


Lineus Medical, Fayetteville, AR
www.lineusmed.com  

Lineus Medical is a medical device company solving vascular access issues for nurses and patients through the development of innovative infusion therapy products. The company’s first product, SafeBreak Vascular, received De Novo clearance from the FDA on May 27, 2021. SafeBreak is a break-away connector designed to separate when a harmful force is placed on the IV line. This device was shown to reduce overall IV complications requiring an IV restart by 44% in a randomized controlled trial. Lineus Medical has 41 independent and direct sales representatives in the United States. The company is conducting a $4.5M Series C funding round to scale its direct sales organization and to expand international distribution opportunities.


Liquet Medical, Charlottesville, VA
http://www.liquetmedical.com/ 

Liquet Medical’s mission is to transform the way Venous disease is treated through localized drug delivery, emphasizing patient outcomes and healthcare sustainability. The company’s first product, the Versus™ endovascular catheter, is designed to improve the treatment of Pulmonary Embolism by providing physicians with continuous real-time biometrics through an intelligent catheter-directed system.


Luminelle, Raleigh, NC
https://www.luminelle360.com 

LUMINELLE® is a Femtech startup dedicated to solving the issues of female Uterine and Urological Health. Leveraging our visualization (endoscopic) system, we focus on detection and diagnosis of uterine cancer, bladder cancers, other uterine diseases and potentially rectal cancers. With our simplified, cost-effective and customizable system, physicians can treat patients easily and comfortably in their office. The LUMINELLE SUSTAINE System includes a simple, reusable endoscope, HD optics and advanced visual processing.  The system is paired with a portfolio of Single-Use 360° RotoSheaths for diagnostic and operative procedures. The cornerstone is the proprietary LUMINELLE Bx (Biopsy) RotoSheath. LUMINELLE Bx is the first and only device that allows physicians to easily and quickly diagnose uterine cancer with accurate visualization and adequate sampling. This can replace the >4MM blind biopsies completed annually with a>40% failure rate, over $12B in healthcare treatment costs, and a mortality rate of >20%.


MetasTx, Athens, GA
https://metastx.com 

MetasTx, LLC is developing a pipeline of novel cancer agents targeted at specific solid tumors to treat and prevent cancer cell metastases to extend and improve the Quality of Life for patients with cancer. The MetasTx platform is based upon research, including important discoveries by the co- Founder and CSO, Somanath Shenoy, demonstrating that PAK-1 is important for cancer cell mesenchymal epithelial transformation (MET), which enables cancer cell motility and metastasis. Our initial therapeutic target is prostate cancer (PCa). Shenoy and Brian Cummings, co-Founder and CTO, have demonstrated that IPA-3 inhibits Pak-1 and a liposomal formation of IPA-3 (MTX-101) reduces PCa cell growth and inhibits PCa metastases to lung and restores PCa induced bone resorption. MetasTx will focus on discovery, development, and early-stage clinical trials (FIH; Phase 1 / 2). We intend to conduct late stage (Phase 3) clinical trials through strategic partnerships, and to commercialize through strategic partners, or licensors.


MicroBaric Oxygen Systems, Longboat Key, FL
https://www.microbaric.com

Autism Spectrum Disorder (ASD) has a worldwide prevalence of over 47M people. Every year 1 in 54 children are diagnosed with ASD. Families with autistic children are faced with significant emotional, physical and financial challenges. The impact to healthcare systems is also immense with some estimates putting the lifetime cost between $2.4M to $3.2M per afflicted individual. Yet despite this rapid growth in ASD, an intervention which consistently and comprehensively addresses the spectrum of needs has not been available until now. MBOS’s NEMO (Neurological Enhancement through Managed Oxygen) Platform is the solution. NEMO is a physical platform and treatment process which is easy to use, low risk, adaptable and affordable. The use of concentrated oxygen has been prevalent for decades treating respiratory issues. NEMO treatments use similar principals and can also be administered in the home or suitable non-clinical settings with minimal training. Our pilot studies using these treatments have demonstrated consistent and permanent improvement in the behavior and functioning of all patients.


Moonlight Therapeutics, Atlanta, GA
https://www.moonlighttx.com 

Moonlight Therapeutics (Moonlight) is a pre-clinical stage biotechnology company developing allergen immunotherapies for food allergy. The lead program is for treatment of peanut allergy. The treatment uses a Moonlight’s platform to deliver the therapy through the skin. Moonlight has a worldwide exclusive license to IP for this platform and has received patents from the USPTO for treating peanut allergy. Moonlight has completed a pre-IND meeting with the FDA and gained guidance on pre-clinical and clinical development. All necessary pre-clinical studies are complete and we are preparing to submit an IND for a clinical trial in peanut allergic children. Moonlight is raising funding for this trial.  


Nanochon, Burke, VA
http://www.nanochon.com 

Nanochon’s Chondrograft™ device is a sturdy medical advancement that is one part orthopedic load-bearing implant, one part tissue growth scaffold, and completely revolutionary. Our implant replaces lost or damaged cartilage and encourages new growth using innovative nanomaterial and 3-D printed designs. This technology has the potential to provide a more successful, faster, longer-lasting, and more affordable solution to joint disease and injury.


Nephrodite, Atlanta, GA,
https://www.nephrodite.com 

At Nephrodite, we envision a world where dialysis doesn’t mean stopping your life. We are developing HollyTM, a combined implantable and wearable device that represents a change in the way End-Stage Renal Disease and dialysis care is delivered. As a true kidney replacement solution, one of the greatest attributes of HollyTM is returning autonomy to patients. With continuous clearance of toxins and water exchange, HollyTM eliminates the need for ‘in-center’ hemodialysis, reduces the immobility required for home and peritoneal dialysis and improves health over standard intermittent dialysis. Our device will offer mobility and independence to patients enjoying freedom to do as they choose with their time. We envision a day when patients no longer have to sit in chair tethered to a machine, either at home or a center. We envision a day, when patients will feel energized, empowered and free. 


NeuraStasis, Houston, TX
https://www.neurastasis.com 

NeuraStasis is developing the “AED for Stroke” – a noninvasive, electrical stimulation device to preserve the brain during stroke and to protect patients from a lifetime of disability. In stroke, time is brain. Sadly, less than 20% of current stroke patients reach treatment in time. Newer treatments can be performed 24 hours after a stroke but only if the damage has not grown too large. NeuraStasis is developing an adjunctive treatment that can help bridge care during those precious moments. Using non-invasive electrical neuromodulation, NeuraStasis augments neuronal function acutely to slow down damage – placing neural tissue into stasis. NeuraStasis has collected promising data in healthy humans and is planning a pilot clinical trial to begin within 2022.


OneFul Health, RTP, NC
https://www.oneful.health 

OneFul Health addresses major problems of the large, growing chronic disease market using scalable, patented technologies and a disruptive regulatory plan. Access online, we provide affordable, high-quality chronic treatments, turning daily 3-7 pills into one small capsule or gel packet. We use technology and the latest science to make your medicine work better for you.


OXOS Medical, Atlanta, GA
http://www.oxos.com/ 

OXOS Medical empowers every provider with the capability, clarity, and confidence to make accurate decisions at the point of care. OXOS offers a suite of connected radiographic instruments that allow users to capture health data with minimal training, integrating directly into OXOS’s cloud-based, telehealth delivery platform. We enable anyone anywhere to access radiologic diagnostics at the point of care, expanding availability and changing the way healthcare is delivered.


Perfusion Medical, Richmond, VA
http://www.perfusionmedical.com/  

Perfusion Medical is commercializing PEG-20k/8k, 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 reperfusion 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 PEG-20k/8k is protected by 4 issued patents and multiple international applications.  PEG-20k/8k may be the most dramatic breakthrough in trauma and critical care in decades, could help millions of patients and generate 4 billion dollars a year in sales or more. PEG-20k/8k has been developed at Virginia Commonwealth University over the past decade with $12 million in support from US Army MRDC.


PERSOWN, Inc., Jacksonville, FL
https://persown.com 

PERSOWN’s goal is to bring affordable, rapid testing and a full suite of personal health technologies to more than a billion underserved families around the world. Now more than ever, the world needs rapid, reliable, low-cost, and portable diagnostics. We’re developing an ultra-accurate, low-cost test strip and reader to deliver lab-quality diagnostic results in seconds for infectious diseases like COVID-19 and Tuberculosis, heart attacks, cancers, brain injuries, and much more. PERSOWN has partnered with the global leader in analytics, SAS. With powerful SAS artificial intelligence, visual analytic and data management software, PERSOWN will be able to effectively mine diagnostic data to uncover infection trends and visualize disease hot spots to better monitor and predict outbreaks. These early insights will help governments and health organizations implement practices that reduce disease spread, mitigate impact, and create early interventions. Dr. Robert Redfield, Former CDC Director, has joined PERSOWN as its Senior Medical Advisor.


PhotoniCare, Durham, NC
http://photoni.care 

PhotoniCare has developed a first-in-class, FDA cleared tool to directly visualize the middle ear without surgery. This enables clinicians in primary care and ENT settings to immediately and accurately determine presence of fluid in the middle ear and type of fluid to drive appropriate treatment of ear infections. Ear infections are the leading cause of surgeries, antibiotic use, and hearing loss in children, and otoscopy, the current standard of care, misdiagnoses them half of the time. PhotoniCare’s OtoSight Middle Ear Scope drives quality care and patient/parent satisfaction, while also providing a new revenue stream to clinicians using the device.


Plakous Therapeutics, Winston-Salem, NC
https://plakoustherapeutics.com 

Plakous Therapeutics has developed a patented, platform biotherapeutic to prevent the rare pediatric disease, Necrotizing Enterocolitis and a follow-on indication for Osteoarthritis.  We have generated compelling preclinical data for both conditions, but the unmet medical need and the regulatory efficiencies of NEC as a rare pediatric disease have led us to prioritize the NEC development effort.   NEC afflicts roughly 6% of the 50,000 babies born annually in the U.S weighing less than 3lbs. and carries a 30% mortality rate. Further, NEC consumes $8.0B in overall healthcare costs, including 20% of annual NICU expenditures.  Our Founder and Management team have prior successful start-up experience.  We have been awarded a $1.72M NIH grant and have received rare pediatric disease and orphan drug designations from the FDA. We are currently raising $10.0M to complete IND enabling studies and enter clinical trials.


Rymedi, Greenville, SC
https://rymedi.com 

Rymedi provides a cloud platform for improving the patient-provider experience across health services. Digital workflows and data management automation streamline logistics, coordination and compliance across diagnostic testing, treatment delivery and patient monitoring. The platform cuts service provider costs and enables client revenue growth with simpler, flexible provision of services around patient needs.


SOMAVAC Medical Solutions, Memphis, TN
https://somavac.com 

SOMAVAC® is an early revenue stage medtech company developing solutions to improve post-operative care from OR to clinic. The flagship product, SOMAVAC® SVS, is focused on effective removal, compassionate collection/disposal, and analysis of fluids that naturally develop and accumulate after general and plastic surgery flaps while delivering negative pressure therapy within the surgical site. Early clinical evidence shows a 5-day reduction in time to drain removal in mastectomy patients with SOMAVAC®. Company is launching its technology to Southeastern US and continuing to grow its pipeline of products.


Soundpipe, Charlottesville, VA
http://www.sound-pipe.com 

SoundPipe’s mission is to bring ultrasonic drug delivery to the clinic for safer and more effective therapies. Our first product is designed to treat critical limb ischemia, the most severe form of peripheral arterial disease. Each year in the United States, 600,000 patients are diagnosed with critical limb ischemia, and they undergo 150,000 amputations. Penello, SoundPipe’s first product, is an innovative intravascular drug delivery system that efficiently directs and enhances drug delivery. An ultrasound catheter is combined with drug-loaded microbubbles (microscopic lipid-shelled gas bubbles) to control dose and spatial coverage by “painting” the vessel with drug. Based on procedures currently being performed, Penello has a potential $1 billion treatment market for critical limb ischemia patients in the US. After addressing this unmet need, we will expand into other indications. A Penello prototype is being studied in animal models and has demonstrated a therapeutic effect using 97% less drug than existing platforms.


TendoNova, Norcross (Atlanta), GA
www.tendonova.com 

TendoNova’s Ocelot™ system is a medical technology for treating chronic tendon pain that promises improved clinical outcomes, decreased cost of care, improved patient experience, and improved physician experience. Its elements are a reusable, rechargeable, hand-held device; a single-use disposable component; and a method for providing digitized data as real-time feedback with data capture and analytics.


Trace Orthopedics, Santa Rosa Beach, FL
https://www.traceorthopedics.com 

Trace Orthopedics, LLC is a pre-revenue research, development, and commercialization medical device company, located in Philadelphia, PA, with a focus on image-guided percutaneous reattachment of partially torn tendons. FDA 510(k) eligible and patented minimally invasive tendon fixation fasteners developed by Trace Orthopedics will shift the paradigm for treatment of partial tears by bringing the procedure out of the OR. Existing reimbursement pathway addresses a $2.4B serviceable partial tendon tear market in the US with additional revenue streams from arthroscopic adjunctive procedures and veterinary use. As soon as FDA 510(k) clearance and IP protection are completed, Trace will focus on its first indication of use: repair of partial tear of gluteus medius at the hip. With product improvements and expanding the indications to groin, elbow, shoulder and beyond, the objective is to position for exit upon reaching market driven stage gates.


Tymanpogen, Richmond, VA
www.tympanogen.com  

Tympanogen is a medical device company that provides ear, nose, and throat surgeons (ENTs) efficiency in their practice alongside exceptional care. We do this through thoughtfully designed solutions that fit seamlessly into existing clinical workflows. We develop, manufacture, and market medical devices based on our proprietary gel technology. Our first product, Perf-Fix Otologic Gel Patch, replaces a 2-hour eardrum repair surgery with a 10-minute clinic procedure having the same high success rates. Perf-Fix is for the thousands of patients who undergo surgical eardrum repair following middle ear infection treatment. Perf-Fix will also be the only eardrum repair product with a pediatric indication, making it the only device that can be marketed for the largest patient segment. By moving eardrum repair out of the operating room and into the clinic, ENTs have more operative time for higher-margin surgeries and can increase clinic profitability through increased patient volume.


Yaya Scientific, Nashville, TN
http://yayascientific.net 

Yaya Scientific, LLC develops innovative diagnostic and therapeutic integrated hardware solutions in the area of real-time surgical imaging, leading to more precise procedures with better outcomes for patients. We are a minority owned company formed in 2019 that has formed a close partnership with investigators at Vanderbilt University and Vanderbilt University Medical Center. We are uniquely positioned to engage with physicians who encounter clinical challenges in the operating room that require technical solutions and are able to leverage our R&D resources and partnership with investigators in the school of engineering to develop novel solutions.