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Tuesday, April 20, 2021

SteadMed merges with French company Urgo



French international healthcare group URGO and Fort Worth-based SteadMed announced Sept. 26 that they had merged their North American operations under the name Urgo Medical North America with headquarters in Fort Worth.

The newly formed company will focus on acute and chronic wound care.

SteadMed was created in 2010 by Michael Steadman, who becomes CEO of Urgo Medical North America. Urgo is a family owned international health care group focusing on wound care.

Steadman previously was president of DFB Pharmaceuticals in Fort Worth and helped start that company’s Healthpoint. He also served as president of the Global Wound Therapeutics business for ConvaTec.

He traces his interest in burn and trauma wound care to an early job as firefighter in the Chicago area where he also trained as an emergency medical technician.

“I saw plenty of burns as well as trauma-related wounds — that was my foundation,” he said in a 2009 article in Ostomy Wound Management.

The merger opens the U.S. market to innovative wound care products formerly only available on a limited basis. Including what is described as a revolutionary treatment in diabetic foot ulcer care.

Steadman says his company was not looking for a merger or a sale although a number of companies were interested.

“SteadMed has been a rapidly growing company here, based out of Fort Worth, building our sales organization throughout the United States,” he said in an interview. “But the wound care business is a very competitive marketplace, and we wanted to be able to continue to grow with scale and bring innovative technologies into this market place. It’s one of the reasons that we partnered with Urgo Medical, because of their success on a global scale.”

URGO took a majority stake in the new strategic partnership.

“Setting foot in the USA represents both a key milestone for our development and a strategic priority,” said URGO Group CEO Pierre Moustial. “We are happy to enter this new market with our partner SteadMed, who also has a strong expertise in advanced wound care and who will help us to develop innovative solutions to assist healthcare professionals in reducing healing time.”

Transparency Market Research said in a March report that the global wound healing market was valued at approximately $23.3 billion in 2016 is projected to register cumulative annual growth rate of more than 4.8 percent from 2017 to 2025.

Herve Le Lous, founder and chairman of URGO, says his company does about $700 million in revenue – about half of that in the advanced wound care market – with about 85 percent of the business in Europe. In also does some business in Canada and some in the United States through distributors.

“The time has come for us to invest in the U.S.,” Le Lous said in an interview.

The merger moved quickly.

“Once we met Michael, I think we thought that the fit between the two companies is perfect,” he said.

The meeting was in part luck, Moustial said.

Earlier in the year, Hollister Inc., which was distributing Restore products with TRIACT Technology manufactured by Urgo Medical, announced it was leaving the wound care segment.

That made it the perfect time for the talks between URGO and SteadMed to begin.

Moustial said URGO had been looking for five or more years for a way to enter the U.S. market.

“Clearly SteadMed was the right one, so I think we made the quickest deal ever, because this kind of discussion always last for maybe one year. I think within maybe two or three months it was done,” Moustial said.

It is a complete fit, Le Lous said.

“The brand that Michael sells in the U.S. doesn’t compete with our products,” he said.

But the doctors, the nurses and the purchasing units are the same.

“So it’s the same commercial introduction, but the products are just complementary. The two together bring a very thorough, coherent range of advanced wound care products,” Le Lous said.

“We call on hospitals and wound care centers. That’s where we spend the majority of our time, calling on those centers. We use distributors to get the product to those places, so our sales are sold to people like McKesson, Cardinal Health Care, AmerisourceBergen, Med Line. These are distributors that we sell our product to,“ Steadman said. “They in turn sell those products to the hospitals that our sales force is calling on and introducing those products.”

Short term objectives for the merged company include reaching $50 million in sales annually and doubling the workforce in Texas and the United States. SteadMed currently has 40 employees and is planning to add five sales representatives and as many as three support personnel as growth accelerates.

“So we’ve got to continue to expand our quality and regulatory presence here, and then our national accounts, which is part of sales and marketing,” said Steadman.

The merger will allow launch of “new innovative products in advanced wound care for patients who suffer from wounds associated with diabetes, blood circulation problems, infections and other wound healing complications,” Steadman said.

Urgo Group is well known in Europe and has a presence in 22 countries.

One exciting prospect ¬is the possible introduction into the U.S. market is UrgoStart, a dressing used for diabetic foot ulcer healing.

Diabetic foot ulcers are one of the major complications of diabetes, URGO Medical said in a February 2018 news release.

“Between 19 and 34 percent of all diabetics will develop a foot ulcer at some point in their lives. This very high frequency is extremely concerning, especially bearing in mind that by 2040 some 640 million people throughout the world will suffer from diabetes,” the news release said.

That, Le Lous, led his company to “tackle the most difficult wound in the world, and the most insidious, the most difficult wound to heal … diabetic foot ulcers.”

Not treated properly, diabetic foot ulcer can lead to an amputation, Moustial said.

In the February news release, URGO said with “one amputation carried out every 20 seconds, diabetes is the world’s leading cause of amputation.” Following amputation, life expectancy for these patients is below five years in around 70 percent of cases, well below that of some cancers.

A randomized double-blind study conducted with 240 patients in five European countries compared the efficacy – effectiveness – and tolerance of the UrgoStart dressing to those of a neutral dressing on neuro-ischaemic diabetic foot ulcers, the company said.

The results, published in THE LANCET Diabetes & Endocrinology magazine were that UrgoStart heals 60 percent more patients compared to a well-managed standard treatment and reduces healing time by 60 days compared to the average healing time of 180 days using a standard protocol, the company news release said.

URGO also brings to the table a product called UrgoTul – a contact layer product that can be used on burn wounds. Le Lous said people in Europe call it “the French touch.”

It does not stick to the wound and allows healing but causes no pain to the patient because it does not stick to the affected area.

Moustial says it is not greasy but it does accelerate healing and protects development of the early cells involved in the healing process that can be damaged in the process of simply changing dressings.

Moustial said the product can also be used on patients who suffer from epidermal bulosa – butterfly skin.

A potential issue is that some of the Urgo products may have to be approved by the U.S. Food and Drug Administration for use in the United States and Steadman said that the fact that the products are being actively used with great success in Europe may not make a difference to the FDA.

“We want to work with some folks in Washington to figure out what is the best opportunity to be able to bring this product through in the shortest period of time,” Steadman said, “because they’ve shown statistical significance in results with this technology.”

A potential issue is that some of the products will have to be approved by the U.S. Food and Drug Administration.

Steadman said that the fact that the products are being actively used with great success in Europe may not make a difference to the FDA.

“We want to work with some folks in Washington to figure out what is the best opportunity to be able to bring this product through in the shortest period of time,” Steadman said, “because they’ve shown statistical significance in results with this technology.”

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Paul Harral
Paul is a lifelong journalist with experience in wire service, newspaper, magazine, local and network television and digital media. He was vice president and editor of the editorial page of the Fort Worth Star-Telegram and editor of Fort Worth, Texas magazine before joining the Business Press. What he likes best is writing about people in detail and introducing them to others in the community. Specific areas of passion are homelessness, human trafficking, health care and aerospace.

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