Early History: Symbiosis Corp
The story of the Syntheon founders begins in 1977 in Miami, at Cordis Corporation, Where Tom Bales and Kevin Smith worked together on lithium power sources for cardiac pacemakers and on angiographic catheters. Kevin had an idea of how to ease the job of cardiologists who had to inject viscous x-ray dye through small catheters. Cordis declined to develop the syringe as a product, but Kevin negotiated a contract to develop the carbon-dioxide-powered Servo Syringe independently, giving Cordis an option to market any commercial product.
Kevin and his boyhood friend, Charles Slater, formed S-Squared Engineering, Inc. in 1987 to develop the syringe. Once the product was demonstrated, Cordis exercised its option and wrote a purchase order, with a cash deposit on the first year’s orders. In August 1988, Tom joined Kevin and Charles Slater, and the three set out to develop the product. They renamed the company Symbiosis Corporation, and during their first year they hired a small staff and manufactured the Cordis Hercules Syringe System.
Radial Jaw Biopsy Forceps
The following year, with sales of the syringe dwindling, the company received a call from John Abele , an old friend and founder of Boston Scientific Corporation (BSC) asking if the guys had any ideas for manufacturing low-cost endoscopic biopsy devices. They made prototypes incorporating simplifications and methods for very-low cost manufacturing, and the Radial Jaw Biopsy Forceps resulted, quickly becoming a sales leader for the Microvasive division of BSC. To get the product into production, Bill Box, ex-Cordis, joined Symbiosis. With sales increasing, Symbiosis hired engineers and production managers and moved to a larger facility in Miami Lakes to produce the Radial Jaw forceps.
The year 1990 saw the birth of the medical breakthrough called “less invasive surgery,” which allowed gall bladders to be removed by a simpler and less painful technique than traditional open surgery. Instruments for this kind of surgery were in very short supply and required continual maintenance. Kevin convinced the Symbiosis partners to pursue this opportunity, made some rough prototypes, and showed them at surgical and OB/GYN medical conferences. Several companies came to Miami, seeking to partner with the company to sell their new laparoscopic instruments. Symbiosis entered a partnership with Ethicon Division of Johnson & Johnson to develop and manufacture a complete line of laparoscopic instruments, and within a year several hundred new employees and engineers were making laparoscopic scissors, dissectors, and other instruments alongside their Radial Jaw biopsy forceps line. The company grew to over eight hundred employees by the end of 1991.
Sale of Symbiosis, Inc.
A surprise acquisition offer from a large pharmaceutical company led the partners to engage investment bankers and lawyers to find a buyer for the company. In September 1992 the company was sold to American Home Products Corp., the largest-ever private medical-device acquisition at the time. Operations continued with the laparoscopic instruments and the biopsy forceps line, as well as a series of devices such as trocars, irrigation instruments, and biopsy needles developed specifically for American Home’s Sherwood division.
The partners eventually left the company, each going in different directions. Kevin and Tom founded Environmental Aeroscience Corp. (EAC), a developer of rocket propulsion
IS Holdings, LLC
Three of the Symbiosis partners, Kevin, Charlie, and Tom, joined with some other Miami medical device industry friends to form a new company, which eventually became known as IS Holdings, LLC. The other present-day Syntheon partners, Matt Palmer and Sean McBrayer, joined IS Holdings shortly thereafter. The company began operations in August 1998 in the building which had housed Environmental Aeroscience Corp. and later moved to a larger facility in Doral, Florida.
Vagiport and Brachytherapy Seeds
Their first product was developed for the new field of NOTES (natural orifice transluminal endoscopic surgery). It would allow an OB-GYN surgeon to complete hysterectomies without converting to open surgery. The VagiPort was developed and cleared by FDA.
A miniature radioisotope “seed” device for the brachytherapy treatment of prostate cancer was developed and approved by FDA. Because of a downturn in the brachytherapy market it did not enter production, but the company developed several “impossible” technologies for these devices, such as the ability to turn the radiation from a seed on or off after it was implanted.
RotaSnare and the Endoscopic Needle
A rotary polypectomy snare, the RotaSnare, was developed and sold to Boston Scientific Corp. A flexible endoscopic injection needle was also developed, produced at IS Holdings, and sold to BSC. Evolved versions of these devices are still in use.
The GERD System
Gastro-esophageal reflux disease affects millions of patients, and several companies have sought to develop a device-based less-invasive surgical cure for the disease. IS Holdings spent several years developing its GERD System, which enabled endoscopic surgeons to apply a titanium clip to a fold formed at the gastro-esophageal junction. Over fifty human patients were treated, nearly all of them being cured of their disease. A new requirement from FDA to perform expensive additional clinical trials caused the company to terminate the project.
IS Holdings developed a self-expanding superelastic metal stent under contract to Edwards Lifesciences, which produced it as the LifeStent. It became one of the most successful peripheral self-expanding stents on the market.
The company worked with Dr. Brud Lary to develop a treatment for varicose veins and formed a subsidiary, VeinRx, funded by a venture capitalist group. The device enabled doctors to close veins in the legs using sclerotherapy. Several versions of the VeinRx infusion catheter were developed and underwent clinical trials.
KMS, named for Kevin, Matt, and Sean, was formed in 2005 to pursue medical device development in the field of endsocopy (with Ethicon) and catheter therapy for chronic totally-occluded arteries (with Novoste Corp). The company occupied the old EAC building to pursue these projects and soon began to work on other projects with Ethicon, including advancements in surgical stapling as well as a line of products for Ethicon’s new endoscopic division, InScope. Products developed for Inscope included an improved disposable biopsy forceps, a multiple-fire clip applier for use through endoscopes, and a variety of other GI instruments. Soon, KMS, renamed Syntheon LLC, focused its work on endoscopic stapling.
Environmental Aeroscience Corp.
During this time, the aerospace company EAC had pursued various projects for the Department of Defense. The last major project at EAC was led by Derek Deville and Korey Kline and developed, under contract to Scaled Composites Corp., a manned rocket propulsion system for Burt Rutan’s SpaceShipOne, the first civilian manned spacecraft, which won the Ansari X-Prize. After completing that project, Derek and Korey joined Syntheon as senior engineers.
The first product developed by Syntheon was an improved articulated endoscopic stapler for Ethicon. Later, Syntheon developed an electrically-powered stapling system for Ethicon. These technologies are now present in the market-leading Ethicon Flex and Ethicon Flex Powered endoscopic surgical staplers. Syntheon also developed and sold to Ethicon a proprietary technology to prevent the use of counterfeit components with their devices.
A group of projects was pursued to develop various techniques for changing the shape and stiffness of devices such as endoscopes and catheters. The EndoGrip, an ergonomic handle to ease guidance of flexible endsocopes, resulted and was approved and produced for a short time. The variable-flexibility technology continues to be developed, most recently for application to the field of interventional neurosurgery.
Ultrasonic and RF Vessel Sealing
Syntheon developed a pair of systems to seal and sever arteries and other ducts in the body using ultrasonic and radio-frequency energy, respectively. These technologies had required inconvenient, large pieces of capital equipment to be placed in the operating room. Syntheon developed miniaturized, hand-held, self-contained systems to apply these techniques without the need for cords or large, AC-powered equipment. Both systems utilized advanced lithium-polymer batteries, high-efficiency power electronics, and hermetically-sealed sterilizable, reusable electronics and battery assemblies. The technology was sold to Covidien, and the Syntheon team then completed the development of the ultrasonic device, manufacturing pilot lots and finally transferring the product to Covidien.
Transcatheter Aortic Valve Replacement
In 2013 Syntheon formed Syntheon Cardiology to develop a catheter-placed aortic replacement valve with Dr. Richard Cartledge. Using micro-mechatronic technology, a complete heart valve and delivery system was developed that allows the surgeon to remotely manipulate and re-shape the valve inside the patient’s heart to achieve optimal fit and function. This technology was sold to Edwards Lifesciences.