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Stedical Scientific: Revolutionizing Wound Care for Burns and Chronic Wounds

Ramin Eghbali, General Manager, U.S

Dr. Aubrey Woodroof, a world-renowned biochemist, is a never-to-be-forgotten name when considering the advancements made for temporary skin substitutes. He was the brain behind the invention of the first temporary biosynthetic skin substitute – Biobrane (cleared by FDA in 1979). Biobrane’s technology marked a remarkable feat in the burn wound care market as it was substantially better than other temporary skin substitutes, including pig skins and human amniotic membranes. Not only was Biobrane as effective as the gold standard of temporary skin substitutes – frozen cadaver allograft, but it was also considerably more economical than the latter.

Decades after pioneering Biobrane, in 2013, Woodroof invented a significantly more advanced generation of that wound care technology named – PermeaDerm. Remarkably, PermeaDerm became the first variable porosity Biosynthetic dermal template introduced in wound care. Woodroof has been adopting a bootstrap approach to developing and enhancing the capabilities of PermeaDerm ever since. In that regard, Woodroof already has multiple patents for enhanced properties of PermeaDerm’s technology, such as variable porosity, increased adherence, and better microbial protection, which leads to better healing of burn wounds.

Notably, Woodroof’s PermeaDerm has significant backing today on its mission to break new grounds in the very competitive U.S. wound care market, in the form of Stedical Scientific. Founded by two visionaries in Lin Sun and Leo Spiegel, Stedical Scientific is a China-U.S. corporation that focuses on unmet needs and large growth market opportunities in healthcare. Stedical Scientific has been witnessing a critical void in the wound care market that it’s vying to fill in currently. “As Biobrane is no longer available in the U.S. market and surgeons have gradually stopped using xenograft (pigskin derivatives) for burn wounds, there is a notable vacuum in the wound care market,” notes Ramin Eghbali, GM of Stedical Scientific. “PermeaDerm has a unique set of attributes that in totality are unmatched,” says Ramin Eghbali, GM of Stedical Scientifics. “A five-year shelf life, simplicity of use, patient convenience with no dressing changes and lower price point make PermeaDerm extremely competitive in a very crowded space with many advanced wound care technologies that come at very high price points, which hospitals have to absorb under the DRG reimbursement model. That is not the case with PermeaDerm. With PermeaDerm, you get a high tech temporary dermal template that is very effective, safe with a unique set of attributes that are unmatched at a very affordable price point,” adds Eghbali.

Underlining this notion, PermeaDerm has been an overnight success within the burn community across the country after being brought to the market by Stedical Scientific. Eghbali attributes this swift success to the widespread acclaim that Woodroof enjoys within the domain and the technologies Leaning on PermeaDerm’s powerful advanced wound care technology as a baseline, Stedical Scientific is all set to find and deliver more clinically safe and cost-effective ways to treat all kinds of burns today performance in the clinical setting. “Woodroof is also the Chief Science and Medical Officer of our company. His decades of research and collaboration in the space enables us to foster a close relationship with the top-tier surgeons in the country within the burn surgery space,” states Eghbali. “We literally have no complaints from surgeons about this technology, which is absolutely astounding. We will continue to make any and all improvements necessary based on feedback from our customers and will dedicate ourselves to continued innovation.”

Taking Wound Care to the Next Level

Stedical Scientific puts forth three products for wound care – PermeaDerm B, PermeaDerm G (Glove) for burns and PermeaDerm C for other acute and chronic wounds.

Leaning on PermeaDerm’s powerful advanced wound care technology as a baseline, Stedical Scientific is all set to find and deliver more clinically safe and cost-effective ways to treat all kinds of burns today

What’s setting them apart in the domain is their enhanced and unique properties. For instance, PermeaDerm (B, G and C) have slits in their membranes (2400 slits in B and 4500 slits in C), with which surgeons can adjust porosity by stretching, from zero to whatever the amount the wound requires. These slits in PermeaDerm allow the exudate to escape through and be captured by a secondary dressing like gauze. PermeaDerm is also transparent, providing a window for the physicians to inspect the wound bed. Thus, only the secondary and for gauze dressing has to be removed to get rid of exudate wound inspection. On a similar note, while PermeaDerm has increased adherence, it sloughs off as the wound heals. So, it doesn’t have to be changed after a period, drastically reducing the hassle and pain for the patients while changing the dressing periodically. And not to mention the significant reduction in time and cost. To that extent, PermeaDerm has all other properties required for an ideal Biosynthetic dermal template, like moisture vapor control, free flowing gash exchange across the membrane, excellent strength, better conformability, and so on. PermeaDerm adheres to the wound bed within 24 hours. Once adhered the patients can also attend to their activities of daily living including showering and hygiene and initiate movement (passive and active range of motion) right away.

Dr. Aubrey Woodroof, Chief Scientific/Medical Officer

Riding on the coattails of such capabilities, all PermeaDerm products have gained FDA clearance for usage in a wide range of areas. PermeaDerm B and G Glove have acquired FDA clearance for donor sites, partial-thickness burns, and meshed autograft coverage. At the same time, PermeaDerm C has FDA clearance for a diverse range of acute and cleanly debrided chronic wounds, including much more and partial thickness wounds, pressure sores, venuous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's, post-laser surgery, podiatric, wound dehiscence, trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.

Leaning on PermeaDerm’s powerful advanced wound care technology as a baseline, Stedical Scientific is all set to find and deliver more clinically safe and cost-effective ways to treat all kinds of burns today. The company has a pool of experts headed by Eghbali to propel them on that mission, which includes engineers and specialists in clinical development, R&D, marketing, and regulatory and payer landscape. On that front, the company is vying to expand its footprint not just in the U.S. but also in emerging markets like China.

Meanwhile, Stedical Scientific is also well poised to expand its foothold to other verticals as well. Woodroof has already started advancing the technology behind PermeaDerm in that regard to cater to other potential markets. Woodroof cites that he is very excited about advancing this art of wound care technology. “These new products are going to revolutionize the space with advanced healing properties. We will be issued a patent by the U.S. Patent and Trademark Office (USPTO) and FDA clearance within the next year,” he says.

To add to that, Eghbali concludes his conversation by mentioning, “We just launched a clinical study in partial thickness burns to provide the clinical community with real world evidence that will demonstrate PermeaDerm’s performance. Everyone knows what a significant investment it takes to generate good scientific data. We want the science to do the talking for us and not simply rely on an FDA clearance. We are very fortunate that Dr. Woodroof has such a solid relationship with the burn community, but it is going to take more than that to drive adoption across the burn and wound care communities. In this business, data is everything.”

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Company
Stedical Scientific

Headquarters
Carlsbad, CA

Management
Ramin Eghbali, General Manager, U.S and Dr. Aubrey Woodroof, Chief Scientific/Medical Officer

Description
Stedical Scientific puts forth three products for wound care – PermeaDerm B, G (Glove) for burns and PermeaDerm C for acute and chronic wounds.