The Silicon Review
“KitoTech Medical is focused on proprietary Microstaples that are our core technology.”
Ther are over 50 million wounds in the US and 200 million worldwide each year. Stitches, also referred to as sutures, are the most common way to close wounds, including lacerations and surgical incisions. They have many challenges. They involve painful, long and expensive procedures that require skilled medical personnel. Wounds closed with sutures are prone to infections and lead to scars. A quicker, safer, and easier way is needed that does not lead to scarring and infections, and can be used by a wide range of medical personnel.
In light of the foregoing, we’re pleased to present microMend® — a KitoTech Medical-developed and recently marketed alternative to sutures.
KitoTech is a medical device company that has launched the patented revolutionary wound closure device, microMend. The product incorporates miniature staples called Microstaples into an adhesive backing to close wounds previously requiring sutures. microMend closes wounds with the ease and speed of a Band-Aid while providing the strength of a suture. It has demonstrated outstanding clinical results in closing wounds, including incisions and lacerations, in a variety of surgical and medical specialties. microMend is now being rapidly adopted by physicians and hospitals throughout the country.
KitoTech was recently named one of the ‘Top 10 Medical Device Startups in 2019’ by an industry-leading publication - ‘MedTech Outlook’.
KitoTech is based in Seattle, Washington.
Ronald Berenson: Interview Highlights
Why did you establish KitoTech Medical and what led you to microMend?
The idea behind KitoTech came from my work at the University of Washington. In 2011, I met a professor who was using the polymer chitosan to develop microneedles, which are similar to traditional hypodermic needles used for injecting drugs except for their tiny size. I was familiar with microneedles from my work in drug delivery. Companies had been trying to coat them with drugs for painless drug administration. The FDA considers these combination products - a drug and device. I knew these types of products have a tough time getting through the FDA. Consequently, I wanted to find something that would take advantage of microneedles without putting drugs on them. In studying the literature, I learned that chitosan had wound healing properties. This gave me the idea of using microneedles to close wounds. That’s when microMend was born, and KitoTech was established to develop the product in 2013.
We started by turning these tiny needles into tiny staples by making them at an angle to grab onto and anchor into the skin. Although we tried chitosan and other polymers, this proved challenging. Paul Leung, our VP of Operations, came up with the idea of using the same metal that is in traditional medical staples, which created our proprietary Microstaples. As expected, because they did not contain drugs, microMend did not require FDA review for approval, just a simple registration process that we completed.
How safe is your device as compared to the traditional sutures?
When Microstaples are inserted, they produce tiny holes in the skin and do not enter the wound. In contrast, sutures produce larger holes that act as ports of entry for bacteria and traverse through the wound that further increases risk of infection. This also causes scarring due to direct trauma to the wound. The Microstaples with adhesive backing provide a tight seal of the wound, while sutures are placed at relatively long distances from one another leaving wound gaps that lead to bacterial entry. Finally, sutures require suture needles and using a needle to inject a local anesthetic. This carries risks of needle sticks for the doctor that can lead to serious infections.
The results with sutures are variable since they are dependent on skills of the physician or other practitioner. To close a wound, sutures are tied to bring wound edges together. If sutures are tied too tight, they strangle tissue resulting in infection and scarring. Tied too loose and wounds open up causing infections and also scarring. microMend eliminates these problems. It is as easy to apply as a bandage and not dependent on suturing skills. It is gently applied eliminating risk of tissue strangulation. The Microstaples are at fixed distances from and much closer to one another than sutures further reducing variability and infections. Finally, microMend does not require any needles eliminating risks of needle sticks for the doctor.
Your device is partly invasive. Are there any complications from using this device?
There aren’t any complications because Microstaples are so tiny that they do not cause trauma to skin. They are designed to reach through the upper levels of skin to provide secure attachment, but not so deep as to pierce nerves and blood vessels that cause pain and bleeding. Furthermore, Microstaples produce much tinier holes in the skin than sutures when inserted and thus do not act as points of bacterial entry. They also do not traverse through the wound reducing risk of infections and scarring.
What was the initial response from the users?
When doctors use microMend, they are amazed at how easy and fast it is to apply. The lack of complications and outstanding cosmetic results also impress them. They have found it is especially useful in children since it can be applied like a Band- Aid and thus does not require restraining kids that is needed with sutures. microMend saves time and doctors are able to hand off procedures to others. Doctors like the fact that patients can take the devices off themselves and so they do not need a return clinic visit to remove them in contrast to sutures. With pricing similar to sutures, significant cost savings are achieved with microMend based on reduced time and resources needed with microMend.
Is your device open to the public or do you only sell your device to hospitals?
Today it is used in health care settings, which include hospitals and clinics as well as the military and first responders. We have plans in the future to market microMend to the public given that it is simple to use.
Do you see a sustainable future for this technology? Or are you planning on bringing another similar device into the market?
Our Microstaple Technology is ideal for attaching products to the skin and will remain the company’s core technology. Our current focus is on wound closure, where we have a family of products that is able to close nearly all wounds encountered in the clinic and hospital. However, wound closure is just the beginning. The technology is applicable to wound care, where the Microstaple Technology can provide secure skin attachment of wound dressings and artificial skin that often become detached from the skin. There are also many other exciting opportunities for the technology in the future.
About | Ronald Berenson
Ronald Berenson, MD is a serial entrepreneur who has founded and led several medical device and biotech companies including two that were listed under NASDAQ. He founded KitoTech Medical and serves as its President & Chief Executive Officer.
“microMend® is safer and better than sutures because it is easier and more rapid to use and the Microstaples are extremely tiny thus being painless and eliminating complications.”