Regulatory guy: Gregg Gellman helping three local business hit the market

Monday, November 27, 2017

Source: LinkedIn

The thing about having a nascent biotechnology scene is that lots of companies are dealing with the journey from an idea to a marketable product.

For three local companies, that journey is being led by Gregg Gellman.

The 48-year-old Getzville resident has experience in engineering, patent law and marketing, and has a deep background in helping high-tech products get approved by the U.S. Food and Drug Administration.

Many of those skills were honed during his time at Greatbatch, where he helped develop a rechargeable power drill for surgeons that is now an industry standard.

And he's putting his abilities to work at the following positions:

• Director of regulatory affairs for 22nd Century Group, where he is leading the regulatory push to become the first marketable "Modified Risk Tobacco Product" in the United States. 22nd Century leaders believe their low-nicotine technology is a billion dollar opportunity if it is licensed to major tobacco companies.

The issue is personal for Gellman, who lost a grandmother, grandfather and aunt to health issues caused by smoking.

"In my humble opinion, the way to reduce the harm caused by smoking is to lower the amount of nicotine in cigarettes to less-addictive levels," he said.

• Gellman is also the chief operating officer and a board member of StimMed, where he started working with local doctors James Czyrny and Robert Kaplan nearly a decade ago while Gellman was still at Greatbatch.

The company, which has developed a sock that uses electricity to boost patient blood flow, was formally founded in January 2015, picked up $1 million in venture capital investment in 2016 and subsequently received two U.S. Food and Drug Administration approvals for its product.

Gellman said StimMed is ready to start working with local doctors to use the product while it considers a broader marketing strategy.

• Finally, Gellman is the vice president and chief operating officer at Garwood Medical Devices, which has developed an electrical stimlution device for healing wounds, helping to grow bones and fighting infection.

Gellman and CEO Wayne Bacon founded the company in 2014, and it has since pulled in $3.6 million in venture-capital financing and finalized a deal with the University at Buffalo, which awarded the company a $1.48 million grant.

Garwood is currently pursuing two products – the B.E.S.T. biofilm eradication device and the EnerAid Active wound care device – both of which are patented. Gellman believes FDA approvals are coming that will allow the products to be introduced to limited audiences by summer 2018.

Gellman said the key to any small business in a biotechnology market is three elements: intellectual property to defend your position in the market; a regulatory pathway that supports your intellectual property; and a product that is designed for production so that the FDA allows you to make it.

"My mantra is that small companies that are in the biotech world must move swiftly and quickly to collaborate with regulatory agencies to ensure they get successful market approvals," Gellman said.

Gellman believes that each of his interests is in a position to help people, which gives him a "personal bias" in pursuing each of the companies. None of them has hit pay dirt yet, but they have rapidly progressed in the past few years, raising Gellman's profile in Buffalo's startup community.

He and his wife also have a three-year-old.

"It can be taxing," he said of his many responsibilities. "However, I'm in the game to heal and cure ills in the world. That's what drives me."

The thing about having a nascent biotechnology scene is that lots of companies are dealing with the journey from an idea to a marketable product.

For three local companies, that journey is being led by Gregg Gellman.

The 48-year-old Getzville resident has experience in engineering, patent law and marketing, and has a deep background in helping high-tech products get approved by the U.S. Food and Drug Administration.

Many of those skills were honed during his time at Greatbatch, where he helped develop a rechargeable power drill for surgeons that is now an industry standard.

And he's putting his abilities to work at the following positions:

• Director of regulatory affairs for 22nd Century Group, where he is leading the regulatory push to become the first marketable "Modified Risk Tobacco Product" in the United States. 22nd Century leaders believe their low-nicotine technology is a billion dollar opportunity if it is licensed to major tobacco companies.

The issue is personal for Gellman, who lost a grandmother, grandfather and aunt to health issues caused by smoking.

"In my humble opinion, the way to reduce the harm caused by smoking is to lower the amount of nicotine in cigarettes to less-addictive levels," he said.

• Gellman is also the chief operating officer and a board member of StimMed, where he started working with local doctors James Czyrny and Robert Kaplan nearly a decade ago while Gellman was still at Greatbatch.

The company, which has developed a sock that uses electricity to boost patient blood flow, was formally founded in January 2015, picked up $1 million in venture capital investment in 2016 and subsequently received two U.S. Food and Drug Administration approvals for its product.

Gellman said StimMed is ready to start working with local doctors to use the product while it considers a broader marketing strategy.

• Finally, Gellman is the vice president and chief operating officer at Garwood Medical Devices, which has developed an electrical stimlution device for healing wounds, helping to grow bones and fighting infection.

Gellman and CEO Wayne Bacon founded the company in 2014, and it has since pulled in $3.6 million in venture-capital financing and finalized a deal with the University at Buffalo, which awarded the company a $1.48 million grant.

Garwood is currently pursuing two products – the B.E.S.T. biofilm eradication device and the EnerAid Active wound care device – both of which are patented. Gellman believes FDA approvals are coming that will allow the products to be introduced to limited audiences by summer 2018.

Gellman said the key to any small business in a biotechnology market is three elements: intellectual property to defend your position in the market; a regulatory pathway that supports your intellectual property; and a product that is designed for production so that the FDA allows you to make it.

"My mantra is that small companies that are in the biotech world must move swiftly and quickly to collaborate with regulatory agencies to ensure they get successful market approvals," Gellman said.

Gellman believes that each of his interests is in a position to help people, which gives him a "personal bias" in pursuing each of the companies. None of them has hit pay dirt yet, but they have rapidly progressed in the past few years, raising Gellman's profile in Buffalo's startup community.

He and his wife also have a three-year-old.

"It can be taxing," he said of his many responsibilities. "However, I'm in the game to heal and cure ills in the world. That's what drives me."

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