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At 4331 Veronica Shoemaker Blvd., between Colonial Boulevard and Winkler Avenue, Pennie has been presiding over about 40 employees who make PurePRP, a system that extracts blood and stem cells and then concentrates it before doctors reinject it into patients, many of whom are looking to prolong having joint replacement surgeries or are recovering from torn cartilage and other sports-related injuries.
Patrick Pennie has been around blood for most of his career. He started out in 1987 as a critical-care, open-heart licensed registered nurse, then transitioned to working as a certified clinical perfusionist operating the heart-lung machine during open-heart surgery.
“Having that background, I became very familiar with blood and blood products and what the different components of blood can do,” he says.
That led him to years of research and development in the regenerative medicine field and his venture as president and CEO of Fort Myers–based EmCyte, a medical manufacturing company that produces devices used for extracting platelet-rich plasma (PRP) and stem cell biologics.
Platelet-rich plasma therapy is an emerging treatment method used in medical fields such as sports medicine, orthopedics and chronic wound care aimed at helping the body heal itself faster. After blood is drawn from a patient, the platelets are separated from other blood cells and run through a centrifuge to increase their concentration. Then they’re injected into the patient’s injured or diseased tissue to stimulate healing. Athletes like Tiger Woods and Kobe Bryant have used PRP to recover from injuries.
EmCyte’s products help health care professionals extract and concentrate PRP. The company works with doctors, health care systems and military medical operations around the country and in Canada, South America, Europe and Australia.
Since the company’s founding in 2008, EmCyte has seen 15% to 20% revenue growth over the last 10 years and is currently doing about $30 to $40 million in distributions around the world, according to Pennie.
“A lot of this growth can be attributed to market awareness,” he says. “We’ve done our homework in building awareness in the market about PRP and how it can improve patients’ lives and outcomes.”
Educating both medical professionals and patients about PRP is vital to the company’s success. That’s why it recently launched Gulf
Coast Biologics, a non- profit regenerative medicine training organization where physicians can take courses to learn more about treatments like PRP. “We’re committed to education, and we do this so physicians can really understand the science of PRP,” says Pennie.
A focus on quality and outcomes also helps set EmCyte apart from competitors. In evaluations done by independent research groups like BioSciences Research Associates, EmCyte’s devices have outperformed others on the market.
“We’ve been able to position ourselves so that our quality stands above everything else,” says Pennie. “Our products produce the highest concentrations of growth factors than
any other product on the market, and physicians have great outcomes with patients using our products. And that word-of-mouth and clinical experience have also been driving growth.”
The company’s 40 employees operate out of a 30,000-square-foot facility with state-of-the-art clean rooms where the devices are manufactured. They’re also packed, warehoused and shipped at the same site. “We’ve been able to secure a good property for us in Fort Myers where we can build and grow,” says Pennie.
EmCyte recently introduced a new product for collecting bone marrow that produces better samples for use in regenerative medicine treatments.
It’s also released new, simplified versions of its PRP systems.
Though Pennie has been researching and developing in this field for years, he realizes others don’t have the same familiarity he does. “It’s still considered a young industry,” he says. “Even though it’s become more mainstream in the last seven to eight years, it’s still kind of all-over-the-place as far as knowledge and education regarding PRP. So we’re going to continue with our efforts on education. We’re not in it for retail; we’re in it to really make a difference in patients’ outcomes.”
Patrick Pennie is profusely passionate about patient care and treatment outcome.
That’s how the former cardiac surgery perfusionist pioneered and proliferated platelet-rich plasma and progenitor stem cell biologics treatments for injuries and non-healing wounds. (A perfusionist operates a heart-lung machine.)
Two decades after creating the treatment protocol while working at Lee Memorial Hospital as a critical care and open heart surgery nurse, Pennie’s Fort Myers-based company, EmCyte, is recognized as a global leader in the production of FDA-approved platelet-rich plasma treatment kits. These kits offer orthopedic patients a regenerative autologous healing option to traditional treatment methods, including surgery.
Founded in 2008, EmCyte has weathered competition from global medical device manufacturers by remaining private, nimble and focused on patient care. Pennie employs 40 in his 30,000-square-foot facility in Fort Myers, where the company manufacturers thousands of disposable PRP kits per day. They are delivered by hundreds of distributors worldwide.
Being a business owner was never his goal, however. His passion was patient care, and it’s that focus, Pennie says, that helped the company outlast competitors that imitated his innovation. Along the way, he’s also learned how to steer through challenges inherent in selling something new in health care.
“I never went to business school because I never intended to do business,” says EmCyte Chairman and CEO Pennie, who started his career in 1987. “Still, I’ve been able to navigate the field, deal with competitors and protect our (intellectual property). We have longevity and sustainability because we have been in this business since the inception of this treatment. It took a lot of sleepless nights, a lot of research and a lot of reading and learning to maneuver and understand the market.”
In 2002, Pennie developed the Secquire Platelet Concentrating System. Ten years later he introduced the PurePRP Concentrating System — the first and only point-of-care PRP system that prepared clinical platelet rich plasma without red blood cell content.
EmCyte’s products provide point-of-care treatment. Blood or marrow is extracted from the patient, concentrated into its purest form in a centrifuge, and the resulting platelet-rich plasma is injected into the injured tissue, prompting regenerative healing. The entire process is an outpatient procedure that takes no longer than four hours.
“It’s usually just one injection, there is no downtime and then the healing happens,” says Pennie. “It may be a little painful at first, but that goes away quickly and over time it just gets better. We have patients who go about their daily activities and forget they had an injury. I’ve had it myself so I know how well it works.”
Physicians who administer PRP treatment are not reimbursed by insurance, so the cost is entirely paid by the patient. Pennie says those costs average $1,500 to $3,000 for the one-time treatment, but is typically less expensive than deductibles for surgery. There is also no downtime or follow-up physical therapy required.
“The patient could be looking at arthroscopic surgery or knee replacement,” Pennie says, “and they will choose regenerative medicine first because even if a knee replacement is covered by insurance, you still have a deductible, and most people have high deductibles.”
The cost of the EmCyte PRP kits averages $225 to $275 each. A one-time cost for a tabletop centrifuge is $3,800. EmCyte manufacturers thousands of disposable kits per day, which the company markets to clinics through medical supply distributors across the United States and Europe, South America and Canada.
Pennie prefers to keep EmCyte privately held, he says, because it allows him the freedom to use net revenue as he sees fit. “I don’t like to be restricted, which is why I choose to remain private,” says Pennie. “If I need to focus on developing something I think is going to be beneficial to the patient, I can put the money into it without having to answer to investors.”
That flexibility, Pennie says, allows him to focus on his own marketing strategy, based on developing relationships with distributors and clinicians to develop products rather than solely on profits. He declined to disclose revenues, but adds, “We’re doing very well.”
More patient care focus: On Jan. 21, EmCyte launched Gulf Coast Biologics Training Center in Fort Myers, a new and independent regenerative medicine scientific and educational institute. Its purpose is to establish and standardize evidence-based clinically scientific treatment methodology and to educate and train practitioners.
“I’ve always focused on improving patient outcomes and improving the patient experience,” says Pennie, “and from that perspective, to develop an infrastructure so we manage the type of care that is being provided.”
EVERY SO OFTEN AN ENTREPRENEUR arises inexplicably from the ranks of hard-working, dedicated, educated individuals who later may wish they’d thought of the same thing, but didn’t. That seems to be the case with Patrick Pennie, a 52-year-old native New Yorker trained and experienced as a critical-care registered nurse and open-heart perfusionist who could operate heart-lung machines during cardiac surgery or others requiring “cardiopulmonary bypass to manage the patient’s physiological status,” as one definition describes it.
That would seem to be ambitious enough for any single successful career, but no. Not for Mr. Pennie, who graduated from Barry University and worked in hospitals on both the east and west coasts for years. And he spent a decade fascinated by blood and the ways blood works — thinking about blood, reading and researching, he says — before finally learning not just the science and possibilities for treatments but the ins and outs of manufacturing, equipment and scrupulous government regulations.
EmCyte, based in Fort Myers.
Finally, in 2008 he created the EmCyte Corp., a Fort Myers-based company now selling its product to doctors and medical practices world-wide. Recently, he also opened an independent training and education facility for doctors and others, Gulf Coast Biologics, aimed at sharing the company’s research, medical studies and data, he says.
His idea, now a reality produced entirely in his FDA-approved, faultlessly clean 30,000-square-foot manufacturing site: platelet derived autologous regenerative medicine.
“Autologous” means it comes from the patient, in this case plasma drawn from an individual, reprocessed to be high in platelets and very low in red blood cells, and returned to the patient to heal injuries and arthritis in joints, bones, muscles and tendons.
“It sounds like bragging, but I consider myself one of the pioneers in the industry. I started doing PRP — platelet rich plasma — when the general public didn’t know what it was, or understand what it could offer,” he said.
“Now after almost 20 years of development, we offer one of the best PRP products on the market.”
It’s not bragging when such celebrated orthopedic surgeons as Dr. Alan Bauman at the Bauman Medical Group in Boca Raton, or Dr. Erick Grana of the Regenerative Orthopedic Institute in Tampa, or Dr. Thomas Sievert in Fort Myers, or Dr. Ronald Gardner of Gardner Orthopedics in Fort Myers all confirm the value of EmCyte’s platelet rich plasma — and other products made at EmCyte, where Mr. Pennie now holds two patents and a number of copyrights, including a patent on a centrifuge tube for separating and aspirating biological components, as a company fact-sheet describes it.
Thomas Edison would be proud. Dr. Gardner finds it extremely useful and dependable.
“They started this earlier and I got on board in 2009 — I’ve done about 2,000 sites now with EmCyte’s products,” he says. “It works in just about every arthritic shoulder I’ve used it on. Our greatest success rates come in shoulders, followed by elbows, wrists, hips, and then ankles. “The healthier a person is, the better it works, and the less degeneration, the better it works. So, if you have a bone-on-bone ankle arthritis, it’s probably not going to help.
“But if you have an early arthritis in the shoulder or knee, we can show improvements almost every time.”
A lot of people face those problems, Mr. Pennie notes, especially in an aging population. So the industry is growing. The global market for platelet rich plasma, which EmCyte products are reaching, may hit $400 million in the next four years with a 13.3 percent compound annual growth rate, according to a report in the online publication, Qurate Business Intelligence.
Dr. Gardner has used products from a wide range of manufacturers, he says — “probably every one out there.” One of the things that distinguishes EmCyte products is its cleanliness — it doesn’t break down or cause problems after administration.
“His products are the most reproducible, the least likely to fail or get contaminated during the handling process,” he explains. “That’s huge.”
As Mr. Pennie explains it, EmCyte creates a product “with really high platelet and growth factor concentrations and really low red blood cell content — those are the key elements in PRP.”
Some competing companies sometimes make it in the test tube, but they can’t get the high concentrations or dependability, even though patients will pay as much for treatment with those products as they do for EmCyte products, Mr. Pennie notes.
“So patients have to ask, where is the PRP coming from and how was it made?”
“These are key elements to (an effective) clinical PRP: platelet concentrations of six times or better, with a platelet yield of 80 percent or better, with red blood cell counts of less than 1 percent.
“There are a lot of products that do not provide those types of PRP performance. A lot of patients are out there getting treated by a low-quality PRP — that’s the sad part. Those patients pay between $1,500 or $3,000 to a physician to treat injury, or wounds, or for an aesthetic improvement they may not see.”
Dr. Gardner explains the science of such treatments this way: “The healing properties come from blood, specifically the platelets — you have red, white blood cells, and the platelets are the smallest cellular portion of your blood. You have 300 million in one cc of blood.
“Inside these platelets are packets of growth factors, a whole bunch of different kinds: they increase metabolism, there’s an insulin-like growth factor, (they can) make cells replicate in growing number. They pull stem cells out of your blood stream and direct them to an injured site. So all of these platelets cause you to heal.”
By way of example — platelets in visible form — consider a scab, the doctor suggests.
When a scab heals over a scratch, you’re seeing million of platelets — dry on the outside when they form the hard, firm layer, but moist underneath where the healing occurs.
“So imagine if you took a body of cells that are healing that open wound from the bottom up — imagine if you took them and injected them into an injured tendon, or muscle or bone or joint surface or ligament. None of them would break down. They are 100 percent available.”
To heal. That’s platelet derived, autologous regenerative medicine in a nutshell — or a scab.
Done the EmCyte way it’s good for more than just patients and their doctors, too.
It’s good for the economy.
“We have certified clean rooms, injection mold machines, and we have a host of other manufacturing equipment used according to good manufacturing practices mandated by the FDA,” Mr. Pennie says.
None of that’s cheap.
And the company employees about 40 people in well-paid, med-tech industry jobs.
Every community could use a lot more of that, too.
Fort Myers, FL. June 11, 2019 – Today we proudly announce that we have received FDA 510(k) clearance for the PureBMC® Supraphysiologic Concentrating System to prepare platelet concentrate and a cell concentrate from bone marrow aspirate.
EmCyte, is proud to announce that it has received FDA 510(k) clearance for its PureBMC® Supraphysiologic Concentrating System. The system’s 510(k) number is K183205 and is cleared for the safe and rapid preparation of platelet concentrate and cell concentrate from a small sample of bone marrow aspirate. Bone marrow’s platelet and cell concentrate is the strongest autologous biologic prepared at the point of care. The system’s clearance is uniquely powerful in that it does not require bone marrow aspirate to be mixed or diluted with whole blood, a method that reduces cell potency and strength.
The PureBMC® Supraphysiologic Concentrating System is designed for minimally invasive collection and preparation of bone marrow aspirate through centrifugation. The quality of the system’s BMC biologic is exemplified in its powerful, yet viable progenitor stem cell milieu combined with platelet growth factors and cell mediators. The system’s distinction lies in its ability to remove hemolytic oxidative free hemoglobin from its BMC biologic, a toxic substance that causes oxidative stress, loss of nitric oxide, inflammation, immunosuppression, microcirculatory dysfunction and significant tissue injury. PureBMC® Supraphysiologic is innovative and sets a new safe and powerful standard in BMC biologics.
“The PureBMC® Supraphysiologic Concentrating System is scientifically potent, clinically pure and processes with ease,” said Patrick Pennie, President & CEO of EmCyte Corporation. “It was designed to improve the quality of the bone marrow cell concentrate deliverable we offer to our clients. We believe it has surpassed our expectations with its consistent and exceptional performance. Its inspirational to know that our innovative ideas are improving the lives of so many people around the world.”
About Emcyte Corporation:
EmCyte Corporation®, headquartered in Fort Myers, Florida, is the world leader in platelet rich plasma and progenitor stem cell biologics. Its PURE™ regenerative product solutions have set a new standard in regenerative deliverables with protocol versatility and outstanding recovery performance. EmCyte products are manufactured in its 30,000 square foot manufacturing facility equipped with certified clean rooms and state-of-the-art manufacturing equipment. With over 20 years of experience, EmCyte’s commitment to innovation has made a clinical difference in countries around the globe, and its team of qualified experts are available to provide advanced training and clinical support. To learn more about EmCyte Corporation®, visit https://www.emcyte.com.
Fort Myers, FL. January 23, 2018 – Today we proudly announce the launch of the new and independent regenerative medicine scientific and educational institute, The Gulf Coast Biologics Training Center.
The Gulf Coast Biologics Training Center was launched in an effort to establish and standardize evidence based clinically scientific treatment methodology and to educate and train practitioners on the best use and application of regenerative autologous biologics. The training center is an independent state-of-the-art training facility where attendees can learn, collaborate and fellowship in a vibrant, elegant and modern environment. Its’ membership portfolio consists of experienced and knowledgeable key opinion leaders all of which are either published or established in their field of practice. The courses are carefully structured to help practitioners better understand the enormous benefits of regenerative medicine and its life changing impact on patient outcomes. The courses are presented in collaboration with Albert Einstein College of Medicine and Montefiore Medical Center, Center for Continuing Medical Education (CCME) to provide Educational CME certified activities for its attendees.
“The Gulf Coast Biologics Training Center was established as a stand-alone educational entity that will serve the regenerative community with substantive courses. I am proud to introduce Dr. Peter Everts as our Director, as he is vastly qualified, notably experienced, widely published and passionate about the effective delivery of regenerative care. Our professional and friendly staff will make the center accessible, accommodating and a great place to learn,” said Patrick Pennie, President, CEO, and Founder of EmCyte Corporation® and The Gulf Coast Biologics Training Center.
Gulf Coast Biologics Training Center is located in Fort Myers, Florida and offers a variety of educational and hands-on training programs that use cadavers and live demonstrations. Multiple courses are presented annually and they cover a variety of regenerative medicine topics. In addition to the regularly scheduled courses, there are personalized training courses that are laser focused on the needs of the practitioner. Its’ participants are renowned medical practitioners suitably qualified to train in their field of expertise. The courses are supported by contributors that are relevant to the field and on the cutting edge of regenerative technology. Most importantly, Gulf Coast Biologics in concert with Albert Einstein College of Medicine and Montefiore Medical Center, Center for Continuing Medical Education (CCME), provides Educational CME certified activities for its attendees.
To learn more about Gulf Coast Biologics and its educational programs, visit https://gulfcoastbiologics.com
Fort Myers, FL. October 12, 2019 – EmCyte, the world leader in platelet rich plasma and progenitor stem cell biologics, will be prominently featured nationally and around the world on Kathy Ireland’s award-winning television series, Worldwide Business. The episode will air on Fox Business Network on Oct. 20th.
EmCyte’s CEO Patrick Pennie was recently invited out to Los Angeles by Worldwide Business for an exclusive interview to discuss EmCyte’s continual development and improvement of devices used for autologous regenerative biologics and autologous therapies used to enhance the quality of life. Patrick goes more in depth about his vision and the remarkable impacts EmCyte has had on its practitioner’s experience and patient outcomes.
“We’re more than supporters of these treatments, we’re innovators of treatments and protocols.” says Patrick Pennie, President & CEO of EmCyte “With the good work of our Chief Scientific Officer and key opinion leaders, we’ve been able to conduct a host of clinical trials and research projects. From these projects, we’ve been able to collect good evidence-based information that allow us to develop better treatment methodologies that are more clinically effective for patients.”
Worldwide Business is weekly half-hour show hosted by business mogul, Kathy Ireland, that features global executives sharing their business insights and framing the opportunities shaping their industries. EmCyte’s episode will air on the Fox Business Network on October 20, 2019 at 5:30pm EST. To tune in, use the channel finder at http://www.foxbusiness.com/channel-finder.html to find your local viewing channel. Viewers can also visit EmCyte’s Facebook page https://www.facebook.com/emcyte/ to catch the full interview. It will also be featured on the Worldwide Business social media network pages https://www.facebook.com/tvwwb/, https://twitter.com/tvwwb, https://www.instagram.com/tvwwb/.
About EmCyte Corporation:
Founded in 1999 in Ft. Myers, EmCyte Corporation® is the world leader in platelet rich plasma and progenitor stem cell biologics with products that meet the highest achievable performance standard. With over 20 years of experience, EmCyte has remained committed to innovation that truly makes a clinical difference. In addition, EmCyte’s team of qualified specialists are available for advanced clinical and scientific training and support through their educational division, Gulf Coast Biologics. For more information, please visit www.emcyte.com/.
Fort Myers, FL. December 1, 2019 – EmCyte, the world leader in platelet rich plasma and progenitor stem cell biologics, announces its FDA 510(k) clearance for its Progenikine® Concentrating System for adipose lipoplasty. The system’s 510(k) is cleared for all medical procedures involving the harvesting and transferring of autologous adipose tissue. The system’s 510(k) number is K191564.
The Progenikine® Concentrating System is designed for pure extraction and centrifugal preparation of adipose concentrate at the point of care. It is uniquely equipped with innovation that permits the full and complete removal of oil contaminants and effluent residuals while securing a robustly concentrated adipose treatment sample. This allows the powerful regenerative bioactive substances to work on transferred tissue without hindering influences. Patients will benefit from another PURE autologous biologic that is both richly effective and gentle to the local tissue environment.
“We’re excited about the vast benefits of the Progenikine® Concentrating System.” says Patrick Pennie, President & CEO of EmCyte Corporation. “It’s a powerful biologic with a wide application base allowing it to be a viable choice for a multitude of procedures. Progenikine® has taken its place on the stage of regenerative biologics and provides practitioners with a superior option for adipose concentrate.”
The Progenikine® procedures include Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic and Re-constructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Laparoscopic Surgery, Arthroscopic Surgery.
About Emcyte Corporation:
EmCyte Corporation®, headquartered in Fort Myers, Florida, is the world leader in platelet rich plasma and progenitor stem cell biologics. Its PURE™ regenerative product solutions have set a new standard in regenerative deliverables with protocol versatility and outstanding recovery performance. EmCyte products are manufactured in its 30,000 square foot manufacturing facility equipped with certified clean rooms and state-of-the-art manufacturing equipment. With over 20 years of experience, EmCyte’s commitment to innovation has made a clinical difference in countries around the globe, and its team of qualified experts are available to provide advanced training and clinical support. To learn more about EmCyte Corporation®, visit https://www.emcyte.com.