Friday, February 28, 2014

Ortho Development® Corporation Launches KASM® for Treatment of Knee Replacement Infections

DRAPER, UtahFeb. 27, 2014 /PRNewswire-iReach/ -- Ortho Development® Corporation has received FDA clearance for its patented KASM® Knee Articulating Spacer Molds. KASM is a cement spacer mold intended for use in treating patients who develop an infection after undergoing total knee replacement surgery. 
"KASM is a unique product that addresses a growing need in the total joint replacement market," says Brent Bartholomew, President of Ortho Development. "We have used KASM with clinical success for the past several years in Japan and are excited to finally have FDA approval."
With the increasing number of total knee arthroplasty (TKA) procedures performed in the United States the complication of TKA infection is also on the rise. The current approach in treating infection in TKA is a two-stage revision surgery involving removal of the original implants and temporarily packing the infected joint with antibiotic bone cement as either a static or articulating spacer. Static spacers force patients to keep their infected joint immobilized for 6-8 weeks until the infection is cured and the second-stage procedure is performed. KASM articulating spacers are designed to help preserve the range of motion, joint space, soft tissue tension, and allow for protected ambulation during that time.
KASM offers disposable femur and tibia molds that allow for the creation of temporary articulating spacers. The molds form a smooth articulating condylar surface using antibiotic-laden bone cement.  The molds come in various sizes, offer the ability for a surgeon to customize the spacer thickness based on patient anatomy, and can be overfilled to accommodate existing bony defects. 
E. Marc Mariani, M.D. and Michael H. Bourne, M.D. from the Salt Lake Orthopaedic Clinic in Salt Lake City, Utah assisted Ortho Development's engineers with the development of KASM. Dr. Bourne commented, "The KASM spacer molds are a distinctive new option for the treatment of serious TKA infection. The combined benefit of elution of antibiotics and continued knee motion lead to improved patient comfort and activity both before and at the time of final knee implantation. We anticipate KASM will be invaluable in the treatment of difficult knee infection cases." 
Ortho Development currently markets its products through a network of independent sales reps and distributors in the United States and through Japan Medical Dynamic Marketing, Inc. (Japan MDM) in Japan.
About Ortho Development Corporation
Founded in 1994 and headquartered in Draper, Utah, Ortho Development Corporation designs, develops, manufactures, and markets devices for knee and hip joint reconstruction, spine treatment, and trauma. Ortho Development is a privately-held company with Japan MDM as the majority owner.  Ortho Development is dedicated to making premium products and delivering superior service and value.  For more information, visit www.odev.com.

Published at - PR Newswire

News - SI-BONE, Inc. Announces Medicare Palmetto Removes MIS SI Joint Fusion from Non-Coverage



San Jose, California, February 25, 2014 / PRNewswire / -- SI-BONE, Inc. (San Jose, California), a medical device company that pioneered the use of the iFuse Implant System,® a minimally invasive surgical (MIS) device indicated for fusion of the sacroiliac (SI) joint, announced today that the Medicare Administrative Contractor (MAC) Palmetto GBA will begin covering MIS SI joint fusion, including when performed using the iFuse Implant System, effective today, on a case-by-case basis. Specifically, Palmetto has removed the CPT® code, 0334T, which is used by physicians to report the iFuse procedure, from their list of non-covered services. Palmetto is one of eight Part A/B MACs in the United States and the first to make this decision. The change will enable Medicare beneficiaries to receive coverage for the iFuse procedure throughout the states of North Carolina, South Carolina, Virginia and West Virginia. This coverage decision by Palmetto was based on published clinical data demonstrating the safety, effectiveness and clinical value of the iFuse procedure. 

“To ensure Medicare beneficiaries have access to the latest effective, evidence-based treatments, Palmetto GBA now allows access to MIS SI joint fusion for patients suffering from degenerative sacroiliitis or sacroiliac joint disruptions who fail conservative therapy. By removing the procedure from the non-coverage list, Palmetto confirms that the procedure is consistent with generally accepted standards of medical practice in the medical community and is safe and effective,” said Michael Mydra, Vice President of Health Outcomes and Reimbursement. 


SI-BONE, Inc. received original 510(k) clearance in November 2008 from the Food and Drug Administration (FDA) to market its iFuse Implant System (then called the “SI Joint Fusion System”) for fracture fixation of long bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, and an additional clearance in April 2011 for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The CE mark for European commercialization was obtained in November 2010. 


Clinical publications have identified the SI joint as a pain generator in up to 22% of low back pain patients.1 In addition, DePalma et al, Pain Medicine 2011, identified the SI joint as a low back pain generator in 43% to 61% of post-lumbar fusion, so-called “failed back surgery,” patients.2 Initial treatment options for patients with SI joint disorders typically involve non-surgical management and, when non-surgical treatment of the SI joint fails, surgical treatments such as the iFuse may provide an option. The iFuse Implant System is a commercially available device in the U.S. and Europe. The iFuse procedure uses a small incision for delivery and implantation of titanium implants. 


The implants are coated with a porous, titanium plasma spray that acts as an interference surface, designed to help decrease implant motion and provide immediate fixation and allow for biological fixation to support long term fusion. These implants have substantial thickness and sophisticated metallurgy and are able to produce a much stronger construct than that of conventional screws used to surgically fix bony structures. The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. As with all surgical procedures and permanent implants, there are risks and considerations associated with surgery and use of the iFuse Implant. 


About SI-BONE, Inc. SI-BONE, Inc. (San Jose, California) is the leading sacroiliac joint medical device company dedicated to the development of tools and products for diagnosing and treating patients with low back issues related to SI joint disorders. The company has developed, and is manufacturing and marketing, less invasive approaches using implants for the treatment of certain SI joint pathology. SI-BONE has an experienced management team with extensive experience in orthopedic and spine medical devices. SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2014 SI-BONE, Inc. All Rights Reserved.  

1- Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clinical Orthopedics and Related Research. 1987;217:266–80. 

2- DePalma M, Ketchum JM, Saullo TR. Etiology of chronic LBP patients having undergone lumbar fusion. Pain Medicine. 2011;12:732-9.



Published at - Si-Bone Press Releases

Thursday, February 27, 2014

Merete Medical is Issued Patents - One for OsteoBridge® (Knee Arthrodesis Rod Fixation System)and One for BioBall® Hip Repair System

osteobridge_diaphysis
Merete Medical has received the FDA clearance to market its Merete OsteoBridge IKA Intramedullary Knee Arthrodesis Rod Fixation System for fusion of the knee joint. Indications include:
  1. Irretrievably failed total knee arthroplastyLimb salvage
  2. Oncology surgery
  3. Any other condition where there is little soft tissue or bony tissue available for support and arthrodesis is the treatment of choice
In contrast to one-piece intramedullary nails, the modular design allows for insertion through a single incision at the knee, with retrograde insertion into the femur and antegrade insertion into tibia. This can be advantageous for an obese patient, in whom the approach to the piriformis fossa is difficult. At the same time the system accommodates dissimilar diameters of the femoral and tibial intramedullary canals, thus achieving a better press fit and stabilization of Femur and Tibia. Also, unlike the situation with a standard intramedullary nail, the physiological genu valgum of the extremity can be maintained. In contrast to a one-piece intramedullary nail, the modular system with its two components fixed with a stable coupler, allows the accommodation of the nail to the contour of the femoral shaft, thus reducing the risk of fracture during insertion.
Published at - Meret New Portal
---------------------
Merete Medical GmbH, Germany today announced that the United States Patent and Trademark Office has issued two new Patents. One directed to OsteoBridge® Implant Family and one to BioBall® Hip Repair System, two innovative products developed by Merete: U.S. 8,518,122, and U.S. 8,533,968.

The OsteoBridge® new invention is based on the problem of providing a modular hip prosthesis for the management of large bone defects or resections by using the proven patented concept of the two hollow shells OsteoBridge® Spacers, used since years in knee arthrodesis and diaphyseal bone defects or resections. The second invention describes method and device for determining the compatibility of tapers to help the surgeon to select the correct BioBall® Sleeve in hip revision arthroplasties.

About the Company

Merete Medical GmbH, founded in 1996, is an owner‐operated medical technology company located in Berlin, Germany. The company focusses on innovative Research and Development and is producing individual solutions for hip revision, foot surgery, and treatment of major bone defects, bone oncology, periprosthetic fractures and trauma implants. The company sites are in Berlin (Germany), Luckenwalde (Germany), New York (USA) and Wroclaw (Poland), Paris (France) Additionally, the Merete forefoot reconstruction product line offers a complete range of proven innovative implants for the correction of moderate and severe toe deformities as well as for bone fusion and fixation.

Published at - Orthoworld

News - Integra LifeSciences Receives FDA Clearance for Integra(R) Titanium Bone Wedges

Integra LifeSciences Holdings Corporation
Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced the introduction of the Integra® Titanium Bone Wedges, designed for internal fixation for bone fractures or osteotomies in the foot and ankle. The system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), and will be featured at the American College of Foot and Ankle Surgeons (ACFAS) 72nd Annual Scientific Conference, February 27 - March 2, 2014, in Orlando, Florida.

The Integra Titanium Bone Wedges may be used in corrective procedures, such as Cotton (opening wedge) osteotomies of the medial cuneiform and Evans lengthening osteotomies. They are composed of commercially pure titanium formed into a cancellous-like structure that mimics the strength and porosity of human bone. The Integra Titanium Bone Wedge is available in 15 different pre-shaped anatomical sizes, to accommodate various skeletal deformities in the foot.

"We're very pleased that we can now offer surgeons another option to complete our flatfoot correction portfolio," said Robert Paltridge, President, Extremity Reconstruction. "Our Titanium Bone Wedges provide more stability over allograft wedges. Additionally, our extensive line of pre-shaped bone wedge implants does not require custom shaping, which helps reduce surgical time."

Osteotomies are procedures in which surgeons realign or remove a segment of bone located near a damaged joint to help correct deformities, typically in the foot. Bone wedges are designed to provide bone grafting material for osteotomy corrections. They provide a scaffold for bone growth, as well as biologic stability and structural support for deformity corrections. Ancillary plates are used to hold bone graft material in place and prevent it from expulsion.

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery. For more information, please visit www.integralife.com.

This news is intended for education purpose. Published at - IntegraLife Investor Relation Section

News - EDGE™ Orthopaedics Receives First FDA 510(k) Clearance for BITE™ Compression Screws


EDGE™ Orthopaedics, a new entry into the orthopedic medical device space, is excited to announce they have received their first FDA 510(k) clearance for BITE™ Compression Screws. Established in mid-2012, the company has embarked on building a robust quality system and developing a platform of products that once on the market could make an immediate impact.
According to Dr. Stephen Brigido, President and CSO of EDGE Orthopaedics, "compression screws are used in approximately 90% of foot and ankle procedures and are the backbone of every orthopedic extremity company.  With a comprehensive range of sizes in both headed and headless options – not to mention an extremely low profile head and better "BITE" – EDGE is building a strong foundation for future growth."
With the first cases under their belt and a pipeline of products in development, EDGE Orthopaedics is embarking on a limited launch Q2. A full launch is expected in the second half of 2014 as they receive additional 510(k) clearances.
About EDGE Orthopaedics
EDGE Orthopaedics is a privately held medical device company developing products and solutions for extremity orthopedics. Aiming to always be on the leading-edge of healthcare, the company will partner with surgeons and healthcare facilities to streamline products, processes and vendor management. With a hybrid approach to surgical solutions and distribution, EDGE Orthopaedics strives to continuously improve quality, efficiency, and add value. 
Published at - PR News Wire

News - Stryker ShapeMatch Cutting Guide System Lasted Just 18 Months


The push in recent years toward innovation in surgical techniques that result in increasingly smaller incisions and faster closures of those incisions are thought to increase benefit to the patient by way of fewer complications and faster healing. However, for some patients, the opposite is true, and the recall of the Stryker ShapeMatch Cutting Guide system and corresponding ShapeMatch Cutting Guide lawsuits speak volumes about the tendency for best-laid plans to become derailed by poor execution.


In other words, things didn’t work out as many had hoped. Optimism trumped by reality. But also, as is witnessed by this case (akin to various other medical devices), part of the problem lay with the promise of a good idea not properly vetted through dedicated clinical testing.

The Stryker ShapeMatch Cutting Guide was software-based and designed to assist in pre-operative planning of knee replacement. The idea was to derive a three-dimensional model of a patient’s knee from images obtained through an MRI or CT scan, followed by the use of the ShapeMatch Cutting Guide to select the various device components that best fit the unique anatomy of the patient. Such customization was intended to result in even smaller incisions, fewer complications and faster healing. The benefit for the hospital, of course, is the ability to free up a bed even sooner than standard arthroscopic procedures might otherwise allow.

But for some patients currently serving as plaintiffs in Stryker ShapeMatch Cutting Guide lawsuits, things have not gone quite so smoothly. According to various reports, a software defect in the ShapeMatch system affected the customized cutting parameters that were found not to align with the cutting guides produced.

Stryker Corporation was originally bullish on the new technology when it received 510(k) clearance from the US Food and Drug Administration (FDA) in May 2011. 510(k) is the so-called fast-track approval process that excuses a medical device manufacturer from the need for extensive and costly clinical trials in order to conclusively test a device on selected trial participants before introduction to the wider population. The thinking behind 510(k) holds that knee replacements are already a medically established procedure, thus updates to existing procedures and technology do not require clinical trials, and can therefore circumvent the kind of vetting reserved for new products and technology.

Eighteen months later, in November 2012, Stryker communicated to surgeons that they should immediately discontinue the use of the ShapeMatch Cutting Guide, and hold off ordering any more units. In January 2013, Stryker issued a voluntary recall of the ShapeMatch Cutting Guide system due to Stryker Triathlon Knee Implant injury. While no fault was found with the Stryker Triathlon Knee system itself, or any of the components involved, the fault was found to stem from the cutting guide system that allowed for errors in cutting parameters and individualized component selection. Thus, the reason for Stryker Triathlon Knee Implant injury has everything to do with the ShapeMatch Cutting Guide System, and nothing to do with the Triathlon Knee Implant itself.

There were also examples of cutting guides that were not properly manufactured within the specifications of the original 510(k) clearance guidelines.

For its part the FDA reviewed Stryker’s voluntary recall and ultimately determined the action as a Class I recall, the most serious classification. The FDA, while not commenting on the approval status of the Stryker ShapeMatch Cutting Guide as a 510(k) clearance approval, announced the Class I recall status on April 10 of last year by way of a press release from Stryker, which the FDA posted on its official FDA website.



Disgruntled patients expecting their knee replacement to last upwards of 15 years with trouble-free operation have instead reported symptoms of improper alignment, abnormal and unsavory sounds, decreased mobility, difficulty walking and chronic Stryker Triathlon Knee Implant pain, amongst other complaints. This, mere months following surgery in some cases, or so it is alleged.

Plaintiffs observe that more traditional procedures were much more invasive and required more healing time. But while more traditional surgery is subject to wider complications, traditional knee replacement was found to have a greater potential for success and the realization of the full life expectancy of the joint, rather than early failure.

Hip and knee replacement failures have been found to increase with newer components and surgical techniques, plaintiffs allege. The FDA has received 44 reports of implant failure as of April 2013.


News - Zimmer's Hip & Knee Business and Obama Care?

One of the most surprising trends for health care investors may be the rally in medical appliance companies including hip and knee leader Zimmer Holdings (NYSE: ZMH) .
In the wake of Obamacare, investors were warned companies would face a profit cliff that would unhinge earnings and crater share prices. Yet, Zimmer's shares have marched 16% higher since health care.gov went live last fall, and shares of Zimmer's primary competitor, Stryker (NYSE: SYK)  are trading at new highs too. Let's see if that optimism is warranted.
Improving procedure markets

The recession took a toll on discretionary orthopedic surgery as cost conscious patients moved to the sidelines, and higher unemployment reduced work and recreation related injuries. But signs suggest improving employment and consumer confidence are jump starting procedure demand.
The number of total knee procedures climbed from 543,000 in 2007 to 719,000 in 2010. Similarly, the number of hip replacements has grown from 230,000 to 332,000 in the same period. That's good news for Zimmer, a leader in replacement knees, hips, shoulders, and elbows.
With a market share of 26% in knee replacement, Zimmer is the largest in the business, outpacing competitors Johnson & Johnson's ( (NYSE: JNJ) Depuy Synthes and Stryker. Zimmer's knee sales have grown by nearly 8% to $1.9 billion between 2009 and 2013 thanks to the rebound in the number of procedures, and knee revenue grew roughly 10% year-over-year in the fourth quarter. That growth pop last quarter came thanks to a 12% jump in volume, which more than offset a 2.4% drop in prices.
Zimmer's 21% share in the hip replacement market puts it slightly behind Johnson's Depuy. However, rebounding procedure demand is lifting Zimmer's hip revenue too. Between 2009 and 2013, hip sales are up about 8% to $1.33 billion. In the most recent quarter, sales for hip products grew 2.9% year-over-year as volume improved 5%, more than offsetting price pressures.
Better days may be ahead

Zimmer's smaller businesses are growing quickly too. Zimmer extremities segment sales are up 43% since 2009, reaching $194 million last year thanks to 11% growth in demand for shoulder and elbow products. That's an impressive advance, but more impressive is the 55% growth in Zimmer's surgical product sales, which climbed to $432 million in 2013. Sales of Zimmer's trauma and dental products are also up double digits since 2009,   and improvement across all these businesses more than makes up for the 20% drop in spine revenue during the period.
Procedure demand may soon be swelling thanks to aging baby boomers. Active, longer-living boomers who want to maintain their lifestyle and avoid years of arthritic pain are increasingly turning to replacement surgery. A CMS study showing that between 1999 and 2007 the number of hip and knee replacements grew a statistically significant 21% and 65% among Medicare patients backs up that assertion.
Since more than 10,000 baby boomers turn 65 every day, the rising need for procedures has industry watchers expecting the hip replacement market will hit $7.1 billion by 2019, up from $6.2 billion in 2012The global market for knee replacement is expected to grow too, increasing to $10.9 billion in 2017 from $6.9 billion in 2010.
That presents an opportunity for profit growth at Zimmer -- and its competitors -- given industry operating margin may have found its footing in the fourth quarter. If so, rising demand will be leveraged for a bigger bottom line.
Fool-worthy final thoughts

Zimmer's sales grew more than 3% in 2013, generating adjusted earnings per share of $5.75, up 8.5% from 2012.  
Buybacks reduced  the company's share count by 1.7 million shares during 2013, yet after paying for share repurchases and dividends, Zimmer's cash hoard finished the year north of $1 billion, up from $884 million in 2012. Short term debt fell to $0.5 million from $100 million, and long term debt dropped to $1.67 billion from $1.72 billion during the year.
The balance sheet should improve even more this year given the company is guiding for 3% to 5% sales growth and earnings per share of between $6.10 and $6.30. If the procedures head higher, it Zimmer's sales growth will more than offset the medical device tax headwind, in which case recent enthusiasm isn't misplaced.
Obamacare seems complex, but it doesn't have to be. In only minutes, you can learn the critical facts you need to know in a special free report called "Everything You Need to Know About Obamacare." This FREE guide contains the key information and money-making advice that every American must know. Please click here to access your free copy.

Published at - The Motley Fool

Wednesday, February 26, 2014

Education (Law) - Court Rules Autologous Stem Cells Are Drugs—Final Ruling?


This article is published in Orthopedics This Week - Link

A “Mixture” processed from a patient’s own mesenchymal stem cells (MSCs), placed in a solution to culture and then combined with an antibiotic doxycycline and injected back into the patient, is a drug and therefore subject to FDA regulation.

But scientifically, that is a very difficult position to support. Which begs the question: Does bad science make good law?

On February 4, 2014 the U.S. District Court of Appeals for the District of Columbia in the case of United States of America v. Regenerative Sciences, LLC ruled that Dr. Chris Centeno was indeed making a “Mixture” of autologous MSCs and that is a “drug” and therefore subject to FDA regulation.


Chris Centeno, M.D. and his partners at Regenerative Sciences argued long and hard that their process did NOT create a “Mixture” but rather simply expanded the patient’s own cells and was, therefore, the practice of medicine and regulated by individual state medical boards. Not the FDA.
Chris Centeno, M.D.

In point of fact, Dr. Centeno had fully complied with the FDA ruling several years ago and was pursuing this very expensive litigation simply for the principal of the matter. His practice is unaffected by either the FDA’s previous ruling or this court’s ruling.

In view of what is scientifically correct and best for his patients, Centeno made the decision to use an antibiotic (doxycycline) during the culturing of the patient’s own cells.

Most doctors’ office in the U.S. have items that are combined with other items (mixtures) for injection that have travelled from another state to that doctor’s office.

So, in Centeno’s view, the principle at stake here is whether the FDA can regulate such common medical activities—especially if they are based on the physician’s own medical and scientific training and judgment. The D.C. court may well have opened the door wide to just such micro-regulation.

FDA Warning and Physician Challenge

At a huge cost in time and dollars, Dr. Centeno fought his battle all the way up to the D.C. Circuit. He is not a wealthy man and this appeals court ruling may be the last stop of a journey that started in 2008 when the FDA sent a Warning Letter to Regenerative.

The FDA charged that Regenerative’s procedure violated 21 CFR 1271.1—FDA’s human cell, tissue and tissue-based products (HCT/P) regulation—by running afoul of its “minimal manipulation” provisions and because the resulting stem cells were not “intended for homologous use only.” Of course, it was a bit of a head scratcher to say that using a patient’s own cells was not homologous use. But, given that interpretation, the procedure did not qualify as an HCT/P product and was therefore a drug.

The physicians of Regenerative disagreed and filed a lawsuit against the FDA in 2010 challenging the characterization of its Regenexx procedure. A July 2012 decision by the U.S. District Court sided with the FDA’s interpretation of the regulations.

Centeno’s Battle

Dr. Centeno and his partners appealed that decision.

“Since 2008, we have been challenging the FDA on whether a physician creating autologous, more than minimally manipulated cells (>MM) for his or her own patients was creating a drug or practicing medicine. This has always been an uphill battle, but one we felt was worth it as physicians do things everyday which should be regulated by FDA (if they weren’t physicians). For example, if you mix drug A and B, technically you need an IND (Investigational New Drug Application) for a combination product. If you alter an existing surgical tool, you would need an IDE (Investigational Device Exemption),” Dr. Centeno told OTW.

He added, “Despite all of our efforts, the D.C. Circuit ruled that your little medical practice can be regulated like a Pfizer drug factory if you use more than minimally manipulated autologous cells. While we’re not happy about their ruling, we fully accept that this is the law now that has been vetted by the courts and will do our best to follow it to the letter.”

Centeno made it clear that not much changes for his practice as a result of this ruling since they haven’t used >MM cells since 2010, the moment FDA took a formal position that the cells were a drug.

“This doesn’t impact PRP (platelet-rich plasma) or BMC (bone marrow cells) right now, as these fall squarely into the <MM rubric. However, if you’re creating adipose SVF (stromal vascular fraction) by using any method (ultrasound, collagenase, trypsin, etc.) that dissociates cells from tissue, it does apply. The D.C. Circuit opinion means that the novel theories about why many physicians believe their use of SVF isn’t FDA regulated no longer hold water,” said Centeno.

The Decision

Specifically, said the court, two statutes were violated, the Federal Food, Drug & Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., and the Public Health Service Act (PHSA), 42 U.S.C. § 201. The Regenexx “Mixture” did not satisfy the requirements of those laws and was therefore deemed “adulterated” or “misbranded.” “The text of those statutes forecloses” the argument that the Mixture is not subject to regulation said the court.

Defining Drugs and Biological Products

The FDCA defines a “drug” as any “article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” or “intended to affect the structure or any function of the body.” The PHSA defines biological product” in similarly broad terms as any “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative…or analogous product…applicable to the prevention, treatment, or cure of a disease or condition of human beings.”

“Both of these wide-ranging definitions clearly apply to the Mixture, an article derived mainly from human tissue and intended to treat orthopedic diseases and to affect musculoskeletal function. Indeed, appellants do not actually dispute that the plain language of the statutes compels this conclusion,” wrote the court.

The court said Regenerative was urging it to construe the FDCA “in light of purported federalism concerns.” But, said the court, that lacked merit and Regenerative’s arguments boiled down to the following syllogism: “the FDCA was not intended to infringe on states’ traditional role in regulating the practice of medicine; the Procedure fits Colorado’s statutory definition of the ‘practice of medicine’; therefore, the FDA’s regulation of the Procedure exceeds the FDA’s authority under the FDCA. This syllogism is flawed twice over.”

Practice of Medicine v Regulating Drugs

First, said the court, Regenerative’s legal argument “misapprehends what this case is about,” by attempting to characterize this case as an effort by the FDA to “restrict the use of an autologous stem cell procedure.” However, said the court, the focus of the FDA’s regulation is the Mixture. “The FDA does not claim that the procedures used to administer the Mixture are unsafe; it claims that the Mixture itself is unsafe. Appellants’ arguments about the practice-of-medicine exemption are therefore wide of the mark.”

Second, the court added that Regenerative is, “wrong to suggest that the scope of the FDCA depends on state-by-state definitions of the ‘practice of medicine.’”

“While the FDCA was not intended to regulate the practice of medicine, it was obviously intended to control the availability of drugs for prescribing by physicians.” Regenerative’s legal construction of the FDCA, added the court, by contrast, “would allow states to gut the FDCA’s regulation of doctors, and thereby create an enormous gap in the FDCA’s coverage, by classifying the distribution of drugs by doctors as the practice of medicine. Such a construction is not tenable.”

Equally untenable, said the court, is Regenerative’s contention that because the procedure occurs entirely within the state of Colorado, the Mixture lacks a sufficient connection to interstate commerce to permit federal regulation under the Commerce Clause.

Citing precedents dealing with the growing of marijuana and wheat for personal consumption, the court said the Mixture does “undoubtedly have effects on interstate markets for orthopedic care, [and] actually includes an article shipped in interstate commerce, namely, doxycycline.”

“We therefore hold that, by virtue of its use of doxycycline, the Mixture is within the scope of drugs—and, by extension, biological products.”

Failing the Minimal Manipulation Test

The court dismissed Regenerative’s arguments that the Mixture is exempt from the FDCA’s manufacturing and labeling requirements even if it is otherwise subject to federal regulation.

The FDA promulgated regulations to ensure the safety of [HCT/Ps] used for therapeutic purposes in 2001. Those regulations define HCT/Ps, as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.”

“HCT/Ps may qualify as drugs or biological products, and when they do, the FDA generally regulates them accordingly.” However, noted the court, there is an exemption from regulation for any HCT/P that is no more than “minimally manipulated.”

“Minimal manipulation” of cells means “processing that does not alter the relevant biological characteristics.”

Regenerative claimed the exemption applied to the Mixture, while the FDA said culturing MSCs alters the genes and proteins they express.

To be fair, that notion that culturing MSCs alters genes and proteins is also scientifically difficult to support. Indeed, at OTW’s annual New York Stem Cell Summit, literally dozens of papers are presented annually which directly contradict the FDA’s position.

Issues of Fact

The court gave Regenerative credit for creating a “genuine issues of fact” by submitting expert affidavits arguing that the government’s views are based on scientific studies that do not apply to Regenerative’s culturing process.

But, why let facts get in the way of an intended ruling. According to the court, Regenerative gave no response to other reasons offered by the government. “For example, appellants admit that the culturing process is designed to ‘determine the growth and biological characteristics of the resulting cell population.’”

And in some cases, said the court, Regenerative added substances to the cell culture that “affect the differentiation of bone marrow cells.”

“These concessions are fatal to appellants’ attempt to claim refuge.”

The court also claimed that Regenerative conceded that culturing MSCs affects their characteristics and offered no evidence that those effects constitute only minimal manipulation. Said the court; “they fail to carry that burden as a matter of law.”

Compounding

Regenerative argued that the Mixture is exempt from the FDCA’s manufacturing and labeling requirements because it is a compounded drug.

“A compounded drug must be produced using certain types of ‘bulk drug substances,’ one of which is ‘bulk drug substances…that…are components of drugs approved by the [government]. Appellants assert that the Mixture meets this definition because cultured MSCs are a component of the FDA-approved drug Carticel.”

But even if that were the case, the court said it would not be enough to meet the law. “To qualify as a ‘bulk drug substance,’ an item must be ‘represented for use in a drug, and appellants point to no evidence in the record even suggesting that MSCs are held out for use in Carticel. Appellants therefore fail to establish that the Mixture is exempt from the FDCA’s manufacturing and labeling requirements.”

Adulterated or Not?

The FDCA provides that a drug “shall be deemed to be adulterated…if…the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice.”

The court concluded, “It is undisputed that appellants’ facilities, methods, and controls for processing the Mixture violated federal manufacturing standards in numerous respects. Therefore, the Mixture is per se adulterated, regardless of any other safety protocols appellants happen to use.”

Civics Lesson

Is this the end of a very expensive civics lesson for Dr. Centeno? The court’s ruling is still open to interpretation but initial word coming from the Centeno team is that they will not appeal any further. If this is the end of the legal fight, then perhaps it becomes a civics lesson. The courts, after all, only interpret the law, not make it. The court was very clear that they were not interested in making law in this case and that if a remedy exists, it lies with lawmakers in Congress.