GeniPhys builds momentum with wound care technology

It’s a small company, with just five employees—but it has a big plan. And after 10 long years in the startup phase, GeniPhys Inc. is readying itself for its next big steps: regulatory approval and commercial launch.

The company, based in an 8,200-square-foot industrial space on the northwest side, is developing collagen technology for soft tissue regeneration to address wound care due to injury, disease, congenital birth defects or tumor removal.

In the past three years, GeniPhys has gone from a one-person operation in a Purdue University laboratory to an emerging company with a board full of life sciences veterans and a CEO whose resume includes stints at drugmaker Eli Lilly and Co. and drug contract research organization firm Covance Inc.

It has:

◗ raised $6 million in a Series A round of investment funding;

◗ won a nearly $1 million grant from the National Science Foundation to develop its core technology;

◗ announced plans to hire 43 people;

◗ and won another $500,000 NSF grant “to support regulatory and commercial readiness” of its lead product.

Add it all up, and it seems like a company few people have heard of is on the cusp of becoming the next success story in the Indiana life sciences sector.

“Like many things, all of a sudden it looks like you’re an overnight success,” CEO Andrew Eibling told IBJ. “What people don’t understand is how long it has taken to get there.”

GeniPhys (the name is a combination of “creation of something new” and “physics”) was founded in 2014 by Sherry Harbin, professor of biomedical engineering at Purdue, who has been studying tissue-based technologies for three decades, since her days as a graduate student at Purdue.

For the past 10 years, Harbin has built an intellectual property portfolio, using patented technology developed in her laboratory and licensed from the Purdue Innovates Office of Technology Commercialization. She has conducted more than 50 preclinical studies and has about 10 approved patents.

Harbin has developed a lead product known as Collymer Self-Assembling Scaffold—or Collymer SAS for short. It’s a collagen biomaterial that helps heal tissues that have been damaged by injury or disease.

Collagen is the backbone of all tissue and the most predominant protein in the body. When a person suffers a wound or tissue damage or loss, the body tries to replace that collagen.

“Unfortunately, our bodies aren’t very efficient at producing collagen,” Eibling said. “It’s a difficult molecule for the body to manufacture.”

That difficulty can slow the healing process, Harbin said, and can leave scars.

She said when many people hear the word collagen, they “think, ‘Oh, well, that’s something I can eat,’ or something they might put in their drink, something that can be used for beautification.”

Indeed, collagen is widely used in supplements for joints, skin and muscle mass and is a popular ingredient in cosmetics.

But its regenerative properties in wound care are addressing a huge market. Medicare, the federal health insurer for the elderly, spends more than $32 billion a year on wound care, much of it involving collagen technology. More than 10 million people are affected by nonhealing, chronic wounds.

“The market is witnessing significant growth, driven by the increasing prevalence of chronic wounds, rising geriatric population, and advancements in wound care technologies,” according to a recent study by ResearchandMarkets.

What Harbin has done in her laboratory is to replicate the body’s innate ability to produce collagen. She is using a natural collagen derived from pig hides, which the company says is very similar to human collagen.

Next up

The next milestone for GeniPhys is to present its studies to the U.S. Food and Drug Administration under what is known as a 510-K submission, an expedited pathway to commercialization.

The company says its technology is in some ways substantially similar to products already cleared to be marketed; that provides GeniPhys a shorter path to approval, almost like a generic product, Eibling said.

But even though GeniPhys is following other companies’ collagen products through regulatory submission, it is not a me-too product, he said.

What makes Collymer SAS different is patented technology that allows collagen molecules to self-assemble into a scaffold that can become the building block for cells to grow new tissue.

“That’s the assembly of these collagen molecules,” Eibling said. “And that in itself is very unique in the collagen space.”

The other feature, he said, is that the product generates no inflammatory response. The tissue surrounding the self-assembling material recognizes it as collagen.

Collymer SAS “will be our first product, and we will launch that into the wound-management space,” Eibling said. “That will be our first opportunity for human use and gathering human data.”

The material is stored as a clear liquid in an acidic solution. When it is mixed with a “buffer” to a normal pH range for the human body, it triggers the self-assembly of the collagen scaffold and then quickly forms a solid.

Harbin described the product as a liquid mixture that can conform to any size wound as its transforms from liquid to solid.

“You apply that liquid to your wound, and it flows into the wound bed, and it can fill all the nooks and crannies of that complex wound site,” she said.

The company is investigating additional applications for its technology, including lumpectomies, where studies indicate the product excels as a regenerative breast tissue filler.

The company hopes to get the green light from federal regulators by the middle of next year, after which it plans to ramp up quickly into product launch mode. It told the Indianapolis Metropolitan Development Commission in 2023 that it plans to hire 43 people at an average wage of $40 an hour.

Eibling told IBJ that is still the plan—when the company gets to the commercialization and manufacturing stages. GeniPhys plans to manufacture the core building block of the technology in-house and is working with a contract manufacturer to fill syringes and handle the packaging.

Long run-up

Although the company seems near a huge milestone, for years it was a tiny operation. Founder Harbin now serves as the company’s chief technology officer, but for the better part of a decade, she worked in her lab without any of the typical support systems of a full-fledged company.

That changed during the pandemic, when Indiana life sciences veteran Matt Neff was talking to some people at the Purdue Research Foundation.

Neff, with more than 35 years of experience as an entrepreneur and venture investor, previously served as president and CEO of AIT Laboratories Inc. and as president and CEO of CHV Capital, the venture capital subsidiary of Indiana University Health.

“I told them I had some time to contribute and wanted to find a company where I could help accelerate development and that had good underlying science,” Neff told IBJ.

Officials at the foundation introduced him to Harbin, and Neff came away impressed with the scientific evidence she had built. “This material they had was revolutionary,” Neff recalled.

He learned that GeniPhys had previously tried to raise capital but backed away from the process. In 2020, GeniPhys leaders were ready to try the capital markets again.

Neff offered to form a board of directors, serve as chair and hire an experienced CEO.

Today, the five-member board includes John DeFord, CEO of Samothrace Medical Innovations and former president and CEO of Cook Inc., now known as Bloomington-based Cook Medical, a huge maker of medical devices; and Shaun Hawkins, managing partner at Pier 70 Ventures and a former vice president of new ventures and private equity investing at Indianapolis-based Lilly. The other three board members are Harbin, Eibling and Neff.

After a brief search for a CEO, Neff found Eibling, then a senior partner at a Zionsville pharmaceutical consulting firm. He had a long resume that included 14 years at Lilly, where he started as a financial analyst and worked his way up to director of business development, and seven years at Covance Inc., a contract research organization for the pharmaceutical industry, where he served as vice president of enterprise alliance management.

Eibling also had a bachelor’s in mechanical engineering from Purdue and an MBA from the Indiana University Kelley School of Business.

“He had a very strong background and just a very good personality for this kind of role,” Neff said. “He is very focused and good with people, and he’s good at building alliances.”

Eibling joined the company in April 2021 and within two years had raised $6 million and won numerous National Science Foundation grants.

The company is now seeking funding to support commercialization activities. It estimates that it will need an additional $10 million.

“Fundraising, especially for the medical-device or medical-technology companies, has been extremely difficult in the last several years,” Eibling said.

So the company has elected to raise $5.5 million through a convertible note that it says will bridge it to FDA clearance and some follow-up studies. At that point, with more robust data and milestones under its belt, it believes it will be much easier to raise money.

In the meantime, it is looking for a commercialization partner to give it access to a huge sales force and distribution network.

“And I hope that you and I are talking about another announcement on a partner signing here in the not-too-distant future,” Eibling said. “That would be great.”•