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.”

Something for Everyone: A Holistic, Yet Specific, Look Inside the Life Science Innovation Ecosystem

Ours is a diverse industry ecosystem. We have much to offer life science innovators of all shapes and sizes, investors, solution providers, institutions of higher education including tech transfer offices and more.

In the interest of building and sharing knowledge across the ecosystem, we hope you will find these recent insights, curated and contributed by the Southeast Life Science team, useful.

One perspective from JPM23

“It’s always interesting to track sentiment and overall vibe for the healthcare innovation economy coming into and out of healthcare week in SF every year. In general, 2023 definitely felt like a smaller group [compared to 2022]. Speaking for SVB, we did have a packed calendar with many high quality meetings so it was time well spent.

“The meetings with many growth-stage investors indicated multiple active deals under term sheet (finally), which could be taken as an early sign of settling valuations and the potential for funds with significant dry powder to start putting money to work at some point this year. 

“This difficult fundraising environment may not be entirely over, but sentiment was that there could be light at the end of the tunnel, and hopefully well before the end of 2023.

“Healthcare innovation companies with healthy balance sheets will continue to be able to ride out the storm, and many are becoming more acquisitive due to reduced valuations and market caps of public companies (especially in the biotech sector) which could result in increased opportunistic M&A activity in 2023.

“Only time will tell but it should be an interesting year!” – Scott McCarty, Southeast Life Sciences Co-Chair and Director, Silicon Valley Bank

FDA guidance on clinical decision support software

“People should know that the FDA made significant changes to the Clinical Decision Support Software Guidance so if a product is in that category, the product should be reviewed against the guidance again,” Grace Powers, Founder and Principal Consultant of Powers Regulatory Consulting wrote us.

From Medtech Dive, “…the final guidance goes into more detail about how the FDA interprets the term “intended for the purpose of supporting or providing recommendations to an HCP [healthcare provider or professional] about prevention, diagnosis, or treatment of a disease or condition.” The text now features examples and a discussion of two aspects of software functionality that may affect whether it is used to support or provide recommendations.

“The FDA has also rewritten and simplified a section focused on examples. In the final text, the section is broken into three parts that cover examples of device software functions and two types of non-device software functions. The agency has also created a graphic to help companies determine if their clinical decision support software is a device.”

Sensor technologies continue to reveal impact in innovation, focus on flexibility

From Georgia Tech News, “So many of our current systems for monitoring and diagnostics rely on bulky machines that enmesh motionless patients in a snarl of wires and sensors, [Dr. W. Hong] Yeo says. Cardiac tests like the electrocardiogram can’t provide continuous data, and they only work if patients remain still and do nothing. Sleep studies, on the other hand, subject patients to uncomfortable, atypical environments prone to yield suspect data. These dependencies on motionlessness and unnatural settings activity make the tests highly susceptible to error and limit the value and trustworthiness of their data. 

“To address these challenges and limitations, Yeo’s group designs and manufactures nano-biosensors and bioelectronics. Completely wireless and easy to wear, these “biopatches” look like small stickers or bandages — soft and tiny, flexible and imperceptible — and a single device can track heart rate and other cardiac activity, respiration, blood oxygen concentration, body temperature, brain activity, and more.

“As we begin 2023, Georgia Tech is looking at six young, pioneering researchers who are tackling some of the world’s most complicated issues and working on solutions ranging from feeding an ever-growing population to controlling wheelchairs via wireless brain wave patches.”

Read on. 

For bioscience and pharma: Preclinical implications for novel cell & gene therapies (ICYMI)

Our colleagues at GCMI report, [preclinical implications for novel cell and gene therapies] are a significant departure from the typical preclinical testing requirements to which the manufacturers of these therapies, almost exclusively pharmaceutical companies, are accustomed.

“On the ‘back end’ of a preclinical study for a novel cell or gene therapy, the endpoints may not look like endpoints common to many device studies, predominantly safety and efficacy. Regulatory bodies will require preclinical study endpoints not commonly considered in medical device evaluation including demonstration of the mechanism of action to show how they work, as is required for drugs, not just safety and efficacy.” – Evan Goldberg, Director of Scientific Affairs, GCMI

Read on.

Partner resource available for marketing, SEO and lead generation

Our colleagues at Write2Market have told us they have room to add 1-2 clients to the healthcare practice of their B2B digital marketing and PR agency. As solution providers to Southeast Life Sciences and SEMDA collectively for the past seven years, as well as to our partner GCMI for nearly a decade, we recommend you give them a look as responsible, results-driven custodians of your digital marketing including web and SEO, audience development and awareness resources.

“Based on the high value they provide GCMI in awareness, industry leadership, marketing and lead generation, we confidently recommend our colleagues across the life science ecosystem consider and engage Write2Market for their awareness, engagement, marketing and business development needs,” said GCMI CEO Sherry Farrugia. “In just one specific example, their ability to use storytelling to brand is unique and helped us achieve #1 search return for ‘preclinical CRO.’”

“Like so many of our clients, we run lean. And because our clients tend to remain clients for extended periods, we cycle in new clients as others depart due to acquisition or pure, internal growth. When we aggressively pursue new client opportunities, we believe it is as meaningful an opportunity for the right client as it is for ourselves.” – Write2Market VP, Healthcare, Paul Snyder

Thanks for reading!

The Impact We Make: Our spotlight interview with Ibraheem “Ib” Badejo

“My story starts out much like Shyam’s,” Ib said.

True, but from one continent and an ocean away at its genesis.

Born in Takoradi, Ghana of Nigerian parents and immigrated to Nigeria when he was eight years of age, Ibraheem Badejo earned his undergraduate degree in chemistry in just three years under scholarship from Avila University in Kansas City. But difficulties in PhD studies at Kansas State University manifested in a second chance, like Shyam’s, at the University of Toledo. Ib earned his PhD in organic chemistry from that institution where he was the Robert Whiteford Memorial Scholar for Outstanding Graduate Research and a Petroleum Research Fund Fellow.

It’s true, Ib and Shyam Parekh worked in the same lab at the same time at the University of Toledo on their journeys to careers in life science. By the time Ib completed his graduate studies, he had published 12 scientific papers.

His first industry gig was in the automotive industry developing automotive coating and colorants, but Ib knew he had more to offer humanity than beautiful, colorful cars.

Taking a chance on eagerness and desire

Transition from automotive coating to healthcare occurred after two years of adjunct research and volunteer work at the Medical University of South Carolina School of Pharmacy in the evenings, Closure Medical Corp was recruiting for an organic chemist with polymer experience under Jeff Clark, then Head of RD, Closure Medical Corp. About a week or so later, he called to offered Ib the job, Ib thought he was joking.

“I had very little direct medtech experience for the position,” Ib said. “When I asked him, ‘Why me?’ He cited my eagerness, willingness to learn, prolific inventions at Bayer and strong desire to improve outcomes for those needing care.

“Patients were waiting then, and patients are still waiting today,” Ib said.

The recipient of 25 U.S. patents with others pending, Ib is now Sr. R&D Director, Ethicon External Front End Innovation. Prior to this role, (Nov 2013-June 2021) – Ib was Sr. Dir, New Ventures at Johnson & Johnson Innovation,  focusing on identifying and investing in early stage medtech companies with strategic alignments to Johnson & Johnson MedTech priorities.  Several of such early stage investments led by Ib are now acquired/on-boarded or part of JJDC portfolio.  From his bio, “From 2010 to 2013, Ib was a Research Fellow at Global Surgery Group of Johnson & Johnson, where he was responsible for external and front-end innovations and intellectual property for Ethicon Biosurgery. From 2006 to 2010, he was the Director of Applied Research & New Technology Assessment of novel biomaterials. Prior to that, he was the Chief Scientist of Closure Medical Corp (acquired by J&J in 2005). Prior to joining Closure, he held various positions at Bayer, North Carolina State University, College of Charleston. He currently serves as an Adjunct Professor of Biomedical Engineering at Drexel University.”

What his bio has not yet caught up with is that Ib is currently in his first year studies in the Northeastern University School of Law. Yes, despite all of his experience and accomplishments, Ib is currently a law school student.

Always learning

“I do have a desire to learn constantly,” Ib said. “But more importantly, I’m always reading contracts, trying to get deals done and negotiating. My fluency there is good, but the nuances of intellectual property (IP), like the differences between discovery and invention and what freedom to operate means can easily be the difference between failure and successful commercialization of new medical technologies for the innovator. Earning a patent is one thing. Being able to commercialize the patent is something else.

“Being fluent in the nuances of IP and how those nuances translate into the business of life science innovation should help me be more effective and efficient in my current role and prepare me for possible future ventures helping early stage companies pick the right projects to focus their limited resources.”

Given Ib’s considerable experience in medtech innovation, we hope you find the following Q&A useful.

What advice would you give early stage medtech innovators or startups?

Ib shares insights on a keynote panel at AdvanSE 2022

“Failure is an option. We so often are told that the sky is the limit. That is true, but it rarely comes without important learning that comes from taking risks that ultimately fail to achieve the goal. Try not to let fear of failure get in the way of trying to begin with. Fail fast, learn from the failure and move on. Do your best, then let the chips fall where they will.  When I have a new idea, start a project or new product development , I always ask myself “what must be true” for this project to move forward.  Another way to think about it – What are 2 critical questions that I must answer for this idea to move forward?  What are two or three showstoppers that must be overcome to move the idea forward?

“Equally important is understanding exactly what you are creating and who is going to pay for it. Can you get a CMS code? Will it be grouped with other products in the same code even if the product is superior? Who are your key stakeholders for a successful commercialization? What’s the regulatory pathway for approval? Critically important is the clinical study design and future reimbursement for the technology.  Answering those questions early and at multiple way-points in the technology’s development and commercialization pathway can increase the odds for successful commercialization or preservation of scarce resources.”

What advice would you give those mid-career professionals, especially regarding inclusivity?

“We all need mentors and sponsors. They are critical to our individual career advancement. Be open to suggestions including criticism that might feel negative. Mentors and sponsors, don’t sugar coat those suggestions. Honest and candid discussions help keep the focus for improvement in the right places. Serving on boards and foundations, and giving back to your community is a privilege and a blessing. I have also pledged to my nieces and nephews back in Nigeria that money needed for their education will never be an impediment for them as long as I can help it.”

What needs to change most urgently in the industry and for what effect?

“Covid-19 highlighted a major issue in our delivery of care for diverse populations. The Black community was hit disproportionately hard. This will almost certainly improve if we increase the number of Black innovators in the life sciences and healthcare because they will much more intimately understand the healthcare journey of Black patients, which is far different from others’. The industry needs to be intentional about building trust in diverse patient communities and funding Black and minority innovators, early stage companies and engineers.”

If someone was going to commit one or two things to memory from this, what would it be?

Image credit to Ib, @IbraheemBadejo

“Our lives should be measured by the impact we make. And, yes, patients are still waiting. We should constantly focus on solving big healthcare problems. In just one specific, personal example, my wife passed from sickle cell disease, a predominately Black disease. We can and should use our talents and resources more intensively to reduce the mortality rate of sickle cell disease.

“We focus on delivering solutions for the future. But in many cases the ‘future’ is always upon us.”

We are grateful for Ib’s contributions to the life science and medtech ecosystem including his time to make this spotlight possible and his service as a member of the Southeast Life Sciences Board of Directors.

Taking a Holistic View: Lessons from a ‘Circuitous’ Career in Life Sciences

Our interview with Shyam Parekh, Strategy and Corporate Business Development, Avanos Medical (NYSE: AVNS)


Since 2005 Shyam Parekh has been primarily focused on inorganic growth initiatives for Kimberly Clark Healthcare, Halyard Health and eventually Avanos Medical as the enterprise’s healthcare business evolved. 

“Where can we go from here, two years or five years out from Avanos’ innovation roadmap? That’s been my focus,” Shyam says of his role.

But how did he get “here” and what can others learn from his circuitous career journey?

Shyam was born and raised in Gujarat, India, 7,729 miles – give or take – from Toledo, Ohio. As unlikely as the match seemed, Shyam earned his Ph.D. in organic chemistry from the University of Toledo in 1989 following degrees in chemistry, physics, business and a masters degree in industrial (applied) chemistry from MS University in Gujarat.

A lifelong interest in science, chemistry in particular, drove his studies and his career, but did not come without its challenges.

“I failed miserably in the first semester as a graduate student at Kent State, clearly prior to Toledo, and lost my financial support,” Shyam told Write2Market’s Paul Snyder. “I guess I was right in my hunch that I was not quite prepared when I started my graduate studies in the United States. Do I go back to India or keep trying?

“Somehow, I could not accept defeat. That experience strengthened my resolve to earn a Ph.D. in Organic Chemistry, publish papers and teach chemistry.

“Thankfully, the University of Toledo gave me an opportunity – and I believe the benefit of doubt for my poor performance or experience at Kent State – at least in part because of my complete absence of experience and study in ‘English medium schools.’” 

Like many, Shyam worked hard, overcame the challenges of language, maintained good grades and, as mentioned, earned his Ph.D. in Organic Chemistry from the University of Toledo.


A “No Contest” Post-Doctoral Opportunity 

Subsequently, he had a decision to make between industry or post-doctoral work; a much more predictable, easily-chosen fork in the road to navigate.

“When Professor Barton invited me to join his research group to work on reaction mechanisms at Texas A&M, it presented a ‘no contest’ situation,” Shyam said.

Sir Derek H.R. Barton won the Nobel Prize in Chemistry in 1969 for adding a third dimension to chemical analysis. He served as professor of chemistry at Texas A&M from 1986 until the time of his death in 1989.

“Working with Dr. Barton was a metamorphic transformation in my path,” Shyam said. “It taught more about what an academic research career requires and how research translates into applications beyond the academic corridors than I would have imagined. It also brought out an aptitude for developing research proposals that had me very seriously considering a career in academic research.”

Alas, Shyam transitioned from academia to industry in 1993 upon accepting a chemical research position with Abbott Laboratories (now Abbvie). 


The Intersection of Science and Industry

“I had a wonderful opportunity to work on HIV protease inhibitors in the thick of the AIDS epidemic,” Shyam said. “Over time, I had an opportunity to work in the area of API development; for numerous drug targets such as anti-angiogenesis (oligopeptide based oncology) targets, GERD and anti-infective agents based on macrolide chemistry and many other pharma process research initiatives. This work also involved scale up, technology transfer to various vendor sites, and transfer of manufacturing technologies.

Shyam’s experience as a line management functional lead with Abbott required him to ‘represent the franchise’ to leadership, commonly a Venture Head (SVP level leader) that had the  soup-to-nuts responsibilities from concept to commercial launch, after which the franchise’s project or product would transfer to the commercial operations under the President of Pharma division.

“A holistic view of business, especially how money meets the market, has held high interest for me for a very long time,” Shyam said. “Generally, corporate executives in medium to large enterprises, including the life sciences, ask you to play your position and play it very well. My innate desire to see the whole picture including how basic research in chemical sciences leads to drug programs, how the external innovations are progressing and how all of the ‘parallel journeys’ impact millions of lives motivated me to validate the ability to speak both the languages of business and science fluently by earning an MBA.”

He did so at the University of Chicago in 2003.


Where Corporate Strategy Meets Business Development Through Open Innovation

When Kimberly Clark created a function and opportunity to combine corporate strategy and business development that previously had not existed, he pursued it with vigor.

“Joining acquisition targets with investment rationale and ‘owning’ those transactions fit my holistic interest in business and linked it directly to my life-long interest in science and medicine,” Shyam said. “Ever since, including through Kimberly Clark’s spin out of the health business into Avanos Medical, my interest and focus on innovation in medical technologies has been very, very high. What criteria make a sound business decision for investments in life sciences – where does the money meet the mind and the market – is a question I find continually interesting. Put another way, ‘Is the juice worth the squeeze?’ ‘Is the view worth the climb?’

“Building and continuously refining an open innovation program – one that starts with our own strategic initiatives and then leverages others’ work in the area through strategic alliances like option agreements, joint development & commercialization agreements, structured deals like distribution agreements with metrics for acquisitions – whatever works for both sides – has been highly fulfilling work. Developing and executing on those agreements, undertaking investments in promising early stage companies – whatever is possible to advance innovation from a very wide variety of sources is always an exciting enterprise.”

We hope you will enjoy Shyam’s insights and answers to a few questions in his own words.


What surprised you as you navigated through multiple stages within your medtech career?

“Accountability to the rigor of all aspects of diligence, deadlines, budgets and cross-functional teams is endlessly more intensive in industry than academia. Industry seeks prudence in resource commitment, alignment and goals, not science for the sake of science as there are always competing priorities for corporate resources. 

“Those transitioning from academia to industry are generally not accustomed to thinking this way. They will likely find themselves facing questions like, ‘What have you done for me lately?’ with surprising frequency.

“Beyond measurable results, career growth in industry has just as much to do with perception as potential. Perceptions are like snapshots of you in the minds of your peers or superiors. Who you are, including your true potential, can never be fully known to others until you spend significant time in an organization with them working, contributing and engaging in dialogue with you on multiple fronts.

“Most of your colleagues, including those senior-to-you, know you from brief interactions around program reviews and ‘water cooler’ conversations. Impressions get left behind and those drive perceptions and perceptions drive career development, at least in some part.

“‘I’m about to schedule a meeting. We are going to talk about X. Someone from regulatory will be there,’… those details do not matter in those brief, yet perceptively impactful interactions.

“Better sounds like, ‘The last EU-MDR update that needed to happen is complete. We now have updates from engineering and clinical, but still need input from regulatory.’ Don’t say ‘hopefully.’ Instead say, ‘I anticipate these updates by X and will report to the team accordingly.’ Don’t ask questions to satisfy your own curiosities. Ask questions that move the conversation forward in a team setting.

“Intentionally synthesize your thoughts into succinct, consumable snippets or refined progress reports in a succinct manner. Don’t embellish, don’t ramble, be succinct, state facts and deliver what they seek to understand. These are the marks of an effective communicator, especially in the life science industry.”


What did you learn as you went that you put into action to some very positive effect?

“The hard learnings came later than I would have preferred. This was just my reality. Inside an industry enterprise others’ interest in how your work serves their career is often intense.

“Don’t use jargon or heavy scientific language. Identify and clearly communicate challenges, uncertainties, risks and the mitigation approach. This shift in communication goes hand in hand with a transition from a role deeply embedded in R&D to corporate strategy including mergers and acquisitions.”


What, if anything, would you like to share about diversity, equity and inclusion in the field?

“Inclusion of diverse perspectives is just as important as all other facets of DE&I. Every individual is looking for respect and an opportunity to prove that they too can contribute, that they are vital to a purpose, an organization, a charter. Give sufficient opportunity for the entirety of a team’s perspectives to be heard.”


What needs to change most urgently in the industry and for what effect?

“Giving credit where it’s due, I agree strongly with Boston Consulting Group’s insights on the need for a material change in medtech’s commercial model. One of the key focus areas for the industry is to improve on SG&A allocations and selling costs as the profit pool continues to shrink in most major medtech market segments. This is needed to meet the investor expectations and the changing market demands. The incremental model is not in any way gaining market adoption by taking the price as the requirements for acceptance of new innovations by the practitioners continues to be intensely competitive and demanding due to changes in payer policies. This is another challenge the industry must address. 


If someone was going to commit one or two things to memory from this, what would it be?

“As we know change is the only constant. Business is no different and frequently change happens at very high speed. Economies change and evolve. Markets change and evolve. Thus, organizations need to evolve with varying degrees of speed. 

“Therefore we all have to learn to evolve with it. If you see an opportunity where you may be sidelined or ignored or otherwise ‘boxed in’ based on perceptions that have driven the reality, ask for an opportunity to prove yourself. Seek out opportunities to be helpful in others’ initiatives. It’s hard for anyone to turn down an offer of more help that can advance their work with the potential to shift their own perception – and career reality – in a positive direction.

“Lastly, own your own deliverables. Your future is in your own hands and you need to learn to manage it.”


Thank you, Shyam!

Shyam has recently shared his plans to retire from Avanos in the next 18-24 months.

We wish Shyam all of the best in his future endeavors and thank him for sharing his story, his energy and his insights with the Southeast Life Sciences ecosystem. He has been an active member of SEMDA, Southeast Life Sciences and the broader southeast medtech innovation community for decades. He also serves, and plans to continue to serve, on the Biolocity Oversight Committee and GCMI’s Industry Advisory Board. 

Ecosystem Partner Insights on the Current State of Medtech Design and Development

Southeast Life Sciences’ approach to innovation is embodied in continuous networking, education and funding opportunities that encourage the life science industry to grow.

Our colleagues at the Global Center for Medical Innovation (GCMI) help direct the development, testing, training and commercialization of innovative medical products that improve quality based outcomes and delivery of healthcare for patients. They are also regular publishers of insights intended to keep the ecosystem abreast of the latest in the life science design, development and commercialization landscape.

GCMI Medical Director Dr. Emily Blum and Director of Research and Development Engineering Saylan Lukas recently shared their insights on “State of Medtech Design and Development” including the hot technologies, high demand services, regulatory evolution and common hiccups for innovators to avoid.

  • What’s critical for new technologies currently in development that lean on AI, is to ensure collection of clean, correct, and unbiased data, and then storing and processing it properly.”

  • “More frequent, routine feedback from the FDA’s experts will always limit expenditures and risks a project might take heading down the wrong pathway.”

  • “Even the most basic “ back of the napkin” drawings for a novel medical device contribute to a robust design history file and can be of value to regulators in understanding a device’s origins and intentions. Rule of thumb: if it’s not documented, it doesn’t count.”

We invite you to take a deeper dive into the current state of the medtech design and development ecosystem in the detailed post on the GCMI news and blog.

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.

The Work that Earned DRIVE the First Ever SLS Innovation Award and Lessons to Learn for Life Science Innovators of All Shapes and Sizes

In the early days of the Covid-19 global pandemic, scientists scrambled to understand its nature, transmissibility, identify and create defense mechanisms including therapies and vaccines.

Leaning on Drug Innovation Ventures at Emory’s (DRIVE’s) focus and years of research and development of broad-spectrum, early stage drug candidates intended to combat viral diseases of global concerns, British regulators approved the use of molnupiravir, the first antiviral pill approved for the treatment of SARS-CoV-2.

A relay race to the finish, the first leg of the race to develop an oral therapy for Covid-19 was actually more of a marathon.

David Perryman, JD

The first major challenge was funding the discovery and development effort. “The commercial biotech industry won’t spend resources to develop therapies for a disease and a market that doesn’t exist,” DRIVE CIPO David Perryman told us. “We had to find funding for our broad spectrum antiviral research and the U.S. Government came to the rescue.”[Paul, I moved this and added context]

“Over the course of eight years we focused on oral  broad-spectrum antivirals for existing as well as yet-to-surface high risk viruses. It took a lot of work to find high potential drugs, but we ultimately focused on molnupirovir – known earlier by the internal identification code EIDD-2801,” Perryman said. “It was a massive undertaking, but against all odds we were able to advance the drug to the verge of clinical testing just as SARS-CoV-2 was emerging. 

“The research that lead to the discovery and development of molnupiravir, now a key tool in fighting COVID-19, originated from [DRIVE CEO and Director of the Emory Institute for Drug Development, George Painter III, PhD] and his team’s search to find compounds that interfered with the replication of Venezuelan Equine Encephalitis Viruses, a virus that had been weaponized during the cold war. The compound (EIDD-2801), though, proved to have much broader efficacy, including activity against highly pathogenic coronaviruses such as the original SARS-CoV and its distant relative, Middle East respiratory syndrome (MERS) virus. With an original goal to use EIDD-2801/molnupiravir to treat influenza, Painter and his team were able to quickly redirect their efforts to address COVID-19.

George R. Painter III, Ph.D.

From the Emory University News Center, “In January 2020, [George] Painter met Wendy Holman, CEO and co-founder of the company Ridgeback Biotherapeutics. She and her husband, Wayne Holman, had experience developing an antibody against Ebola and were eager to contribute to the fight against COVID-19. With the extensive data that Emory scientists and DRIVE’s collaborators accumulated on the activity of the drug in animal models with viral diseases, Ridgeback was able to  obtain FDA approval for phase 1 testing in humans. DRIVE and Ridgeback announced a collaboration in March 2020 to move EIDD-2801 into clinical trials, with Ridgeback licensing the technology from DRIVE.”

Continuing from Emory News, In early October [2021], Merck and Ridgeback Biotherapeutics, which developed the drug after licensing it from DRIVE, reported that a Phase 3 study showed that molnupiravir [commercially dubbed ‘Lagevrio’] significantly reduced the risk of hospitalization or death in patients with mild to moderate COVID-19.

“In December, 2021, the FDA issued an emergency use authorization (EUA) for  molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19.”

DRIVE was created in 2012 as a non-profit conduit for translating university based research into commercialization opportunities critical to making therapies available to patients worldwide. Less than ten years later, it had an authorized drug helping save lives during the COVID pandemic. 

DRIVE is still a not-for-profit entity, hyper-focused  on infectious diseases, and seeking to anticipate pandemics or viral disease outbreaks, be they of natural evolution, lab escape or unleashed humans with bad intentions,” Perryman told us. “Our goal today is the same as it’s been since our inception: to address viruses of global concern and get a series of broad spectrum drugs on the shelf that can anticipate pandemics so that whatever viruses  emerge, we have an effective proactive pill to minimize the harm to human life and to world economies.

According to Perryman, Ridgeback sold $3.2 billion in molnupiravir (fueled by advance government contracts) in Q1 2022.

DRIVE Awarded First Southeast Life Sciences Breakthough Award at AdvanSE 2022

At the 2022 edition of AdvanSE, Southeast Life Science’s (SLS) flagship event, DRIVE’s Painter and Perryman were presented with the first SLS Breakthrough Award for the most commercially significant product launched in the past year.

Where is the opportunity for others to learn from DRIVE’s experience. We’ll let Perryman’s words speak for themselves.

“There’s an old lesson that tends to come later in life. What’s critical is to focus on something the world really needs, not what you think it needs, but what doctors and caregivers are telling you they need.

“When demand for your technology is validated, or very nearly validated, form a team among the very best in that technology’s field of opportunity.

“Then, ensure every member of that team is perfectly aligned on the goals and focus, focus, focus. Do not get distracted.

“There will always be a need to spend time on financing, for example, but many high performing scientists, innovators and aspiring leaders can be easily distracted by many other activities that seem to merit their attention, but actually distract from achievement of the primary goal. When that becomes true, successful achievement of the ultimate need and goal diminishes.

“Find and engage the best in finance, legal counsel, science and business development and keep them laser focused on how and why their expertise contributes to a very specific goal.” 

The team at Southeast Life Sciences thanks the DRIVE team for their remarkable contributions to global health, the southeastern United States’ life science ecosystem and Mr. Perryman for taking the time to share his insights with us here.

About DRIVE

Emory University formed DRIVE to advance the development of early-stage drug candidates to address viral diseases of global concern. DRIVE has a leadership team with deep industry experience and applies an entrepreneurial mindset and the focus of a biotechnology company to address the world’s need for therapies that address pandemics, an area that for-profit companies have historically neglected. By taking advantage of Emory’s renowned research enterprise, DRIVE increases the probability that promising drugs will be developed for the ultimate benefit of humanity.  

About Southeast Life Sciences

Southeast Life Sciences is dedicated to the growth of the life sciences industry. It was formed in 2019 through the merger of Southeast BIO and the Southeast Medical Device Association (SEMDA). Our mission is to cultivate, convene, and connect the Southeast entrepreneurial ecosystem to foster life science innovation & investment across the region for the greater good.

We facilitate connections, conversations and capital investments through continuous networking, education and funding opportunities for life-science innovators of all shapes and sizes. We are the proud creator and producer of the AdvanSE Life Sciences Conference, an annual gathering of the most innovative life sciences companies, researchers and discriminating, accomplished investors and corporations that want to do business with them.

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.

On funding, partners and regulatory strategies: lessons from FUSMobile’s efforts to make focused ultrasound significantly more accessible

“FUSMobile has developed the Neurolyser platform as the only non-invasive treatment system optimized to destroy neural tissue associated with chronic low back pain (facet arthritis) and other conditions such as knee and hip arthritis.”

 

The technology uses X-ray guidance to direct multiple high intensity focused ultrasound beams from outside the body to a focal point. Once the acoustic energy converges at the target area, it generates localized heat to ablate the neural tissue, leaving skin and other tissue along the pathway intact.

 

“The proposed investigational use for the technology is designed to reduce the pain and eliminate the risk of infection or bleeding associated with more invasive procedures such as radiofrequency (RF) ablation, which is the current standard treatment.”

 

Ron Aginsky

“Our vision and work started in 2014,” FUSMobile Co-Founder and President Ron Aginsky, LLB, MBA told us. “We took the lessons we learned from past endeavors with the desire to find a better way to introduce focused ultrasound for patients who suffer from pain. We believe with confidence that we have found that path.”

 

From a 2019 profile, “We successfully completed the first in human pilot study (10 patients) in Canada at two sites – McGill University in Montreal and Silver Medical Group, a private clinic in Toronto. The study was initiated by Dr. Jordi Perez at the Center of Innovative Medicine (CIM), which is part of McGill University, and was extended to include Dr. Michael Gofeld from Silver Medical Group.”


As of June 2022, clinical studies continue in Canada and Israel. First patient was already treated in the USA as part of an FDA IDE pivotal study.

 

What have Arik and Ron learned about regulatory bodies and pathways, funding strategies and partners in their experience, both legacy and recent? 

 

Evidence of a massive shift in regulatory pathway and strategy

 

“A lot of innovators hear ‘U.S. FDA’ and start to shiver,” Ron said. “They shouldn’t. The FDA is a valuable resource. We have seen that ourselves. We were initially hesitant to engage the agency directly. But we have learned that if you engage them early and present your idea, they can shape your technology and regulatory pathway with you, along with providing valuable inputs on clinical study design. In retrospect, we should have approached them much earlier and communicated much more frequently than we have done.”

 

Arik Hananel

“Listen closely to what they have to say,” FUSMobile Co-Founder and CEO Arik Hananel, MD, MBA said. “We see, again and again, when we get stuck, we had received the relevant feedback previously, but just missed it. Listen, then implement. Every word they use or share has a meaning. They know what they want to see. They will not lower the threshold, but will do what they can to help you cross it.”

 

“Not long ago, CE mark achievement in Europe was almost always an easier market entry point,” Ron said. “That has changed to the point that today regulatory approval in Europe is much more difficult as the regulatory bodies there undergo a significant transformation. There is a great deal that is not known yet about practical interpretations of new regulations. This puts levels of limitations on companies’ abilities to provide the right information into European regulators’ hands that might make a United States first strategy much more attractive.”

 

Related: The FDA’s Total Lifecycle Advisory Program, set to soft launch in FY 2023, may bring a seismic shift in commercialization pathways and timelines.

 

From Medical Design and Outsourcing, “The long-term vision for a successful TPLC Advisory Program (TAP) is to help spur more rapid development as well as more rapid and widespread patient access to safe, effective, high-quality medical devices of public health importance,” the FDA said in the letter. “A mature TAP will also help ensure the sustained success of the breakthrough devices program.”


A significant feature of the TAP pilot is that it would offer “regular, solutions-focused engagement” between medical device developers and patients, healthcare providers and payers.

 

On funding: always ask more more than you think you need

 

Arik: “We have learned everything costs twice as planned and takes three times longer. Medical device development is much more capital intensive than an app or software. “

 

Ron: “Raise for what you want to do. Value that properly. Do your math. $500,000 will not get a pilot study done. Be transparent.”

 

Arik: “We funded our proof of concept and initial data sets ourselves. Friends and family helped fund early preclinical work needed to develop our first clinical prototype.

 

“More ‘professional’ investors including Atlanta Technology Angels and Orbimed Ventures got us through our initial pilot study. Our most recent round, which included support from Avanos, and existing shareholders should see us almost all the way through our FDA pivotal study and refinement of our follow on commercialization efforts.”

 

Arik told us the FUSmobile team is considering another round of funding in the near future to generate an additional 18 to 24 months of runway including needed buffer, development of additional indications and initialize commercialization.

 

On partners

 

“Our first meeting with Avanos was an incidental one at an industry dinner,” Arik said. We’ve found their entire team, especially engineers, as eager to innovate in the interest of patients first through procedure improvement. It didn’t hurt to be ‘neighbors,’ either.”

 

“Exploring partner relationships is very much like dating,” Ron said. “Feelings and indications of growth, the potential for something fruitful, is important. Enthusiasm, alignment of values and building trust is important. We found all this, and built upon it, with our colleagues at Avanos.

 

“Though this is not specific to funding, be persistent, be flexible, be creative and be willing to do things outside of your scope of skills. I learned how to execute on preclinical work even though my primary role has been [business development.] Conversely, Arik, whose great strength is clinical and engineering, pored over our partnership and investment documentation asking all kinds of valuable questions along the way.”

 

What else would you like to share with the Southeast Life Science ecosystem of investors, innovators, solution providers, universities? 

 

“State level support for medical technology innovation in Georgia needs improvement, especially compared to other states in the region like Virginia, the state in which we originally incorporated FUSMobile,” Ron said. 

 

“We are also eagerly seeking collaborators in the higher ed realm, particularly for animal health research collaboration. We would encourage those interested in that work to contact Arik at arik@fusmobile.com.

 

Southeast Life Sciences thanks Arik, Ron and the Avanos team for making this content available for us to share.

“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