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Wednesday, July 31, 2013 8:26:42 PM
The OS is only 9,778,940 shares which is very tiny.
The MV at the recent high $0.01 is just $97K which is still joke low as a hot bio-tech company or as a clean RM shell.
Note, the available float for trading is less than 1M shares which is super tiny.
The cash value is $2.47M or $0.25 per share.
The revenue is $1.5M or $0.22 per share.
The gross profit is $681K.
The enterprise value is $6,360,000 or $0.6504 per share.
The insiders ownership is 0.6% of OS.
Key technical updating: The 20/50/200-Day MAL is 0.0008/0.0007/0.0011.
Note, The three-year high was $0.35.
The company website: http://www.ivysportsmed.com/
ReGen Biologics, Inc. (RGBOQ) Business Summary:
ReGen Biologics, Inc. designs, develops, manufactures, and markets medical devices for the repair and generation of soft tissue in humans, primarily for orthopedic applications. The company's proprietary collagen matrix technology includes applications in orthopedics, general surgery, spine, cardiovascular, and drug delivery. Its products include Menaflex collagen meniscus implant device, for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus; and SharpShooter Tissue Repair System, an instrument that allows surgeons to place needles in hard-to-reach locations of the meniscus. The company sells its products in the United States, the European Union, the Republic of South Africa, Canada, Australia, Chile, and Japan. ReGen Biologics, Inc. was founded in 1987 and is headquartered in Hackensack, New Jersey.
There are fifteen full-time employees with the company.
ReGen Biologics Inc. (PINK:RGBO) filed for Chapter 11 bankruptcy protection with the U.S. Bankruptcy Court for the District of Delaware.
April 11, 2011 by MassDevice staff
Embattled ReGen Biologics Inc. files voluntary petitions for Chapter 11 bankruptcy protection and announces a $1 million private placement from one of its largest investors.
The embattled maker of the Menaflex knee implant said in regulatory filings that the bankruptcy petition includes the company's wholly-owned subsidiary RBio Inc., but not its wholly-owned Swiss subsidiary, ReGen Biologics AG. The company will use cash flow from operations and proceeds from a loan it received from one of its largest institutional shareholders to pay the bills while it goes through the bankruptcy process.
ReGen said it raised $1 million through a private placement deal with the Sports Medicine Holding Company LLC, a division of Ivy Healthcare Capital II L.P., one of its largest shareholders. The private placement comes in the form of senior secured notes due August 31, which carry a 12 percent annual interest rate.
The bankruptcy filing adds yet another layer to the ReGen story, featuring a protracted and public battle with the FDA for nearly two years that has captured the attention of the medical device industry. Last week, the FDA rescinded its 2008 510(k) clearance of the Menaflex device, a bio-absorbable mesh implant designed to encourage the re-growth of damaged knee cartilage. The rescission means Hackensack, N.J.-based ReGen has to keep the device off the U.S. market until it can prove its safety and effectiveness to the FDA's satisfaction.
ReGen wasn't shy about voicing its displeasure over the rescission, with CEO Gerald Bisbee calling it "totally unbelievable."
The FDA said it wants ReGen to "discuss the appropriate marketing pathway for the device and what data it would need to provide a reasonable assurance of safety and effectiveness," five years after the company began the 510(k) application process.
ReGen has sunk $30 million into meeting requirements set by the FDA's Center for Devices & Radiological Health, according to Bisbee, "only to have the agency reverse decisions made by previous CDRH officials by stating that they were in error with no substantial evidence that is true."
The Menaflex 510(k) clearance in December 2008 came over the objections of FDA scientists who opposed clearing the device. In September 2009 the agency admitted that undue influence from four New Jersey congressmen and former commissioner Andrew von Eschenbach affected the decision to green-light the device and announced an investigation into the foofaraw.
In March, the agency's Orthopedic & Rehabilitation Devices Panel decided that, while the implant is reasonably safe, its effectiveness needed to be further analyzed. That decision came the same week that the FDA released a report saying ReGen failed to produce adequate evidence that device was safe before it was cleared to hit the market.
"It's unbelievable that after more than five years of 510(k) review of this product — and after being told by the ODE Director and the CDRH Director to file two separate 510(k) submissions for this device as a surgical mesh — [CDRH head Dr. Jeffrey] Shuren now says that they were wrong," Bisbee said in prepared remarks on March 22. "This arbitrary and unsubstantiated intention is an example of why the investment community is increasingly wary of investing in companies with products requiring FDA approval."
That wasn't the only shot Bisbee fired across the FDA's bow.
"We and they both know the agency has no legal authority to rescind its clearance of Menaflex. There is ample evidence the FDA completely botched its review of our Collagen Scaffold at every stage," he said. "After six years of unthinkable bias, mistakes and blunders, we are opting out of the FDA's administrative process and pursuing other legal options for continuing to market Menaflex to U.S. orthopedic surgeons and their patients."
FDA Will Rescind Approval of Knee Implant Device
By JOHN GEVER, MedPage Today Senior Editor
Oct. 15, 2010
WASHINGTON -- The U.S. Food and Drug Administration said it should not have approved a collagen-based knee implant called Menaflex under the 510(k) process and will seek to revoke the product's clearance after meeting with its manufacturer.
The product, cleared by the FDA's Center for Devices and Radiological Health in December 2008, came under fire a few months later when the FDA -- then under new leadership -- announced an internal investigation into the approval process for Menaflex. A parallel inquiry began in Congress at the same time.
The FDA has now concluded that the 510(k) process was inappropriate in this case because Menaflex "is intended to be used for different purposes and is technologically dissimilar from devices already on the market."
Read this story on www.medpagetoday.com.
It also cited findings from its internal investigation suggesting that "external pressures" had influenced the device's review.
Menaflex is a crescent-shaped piece of resorbable collagen-based material that is surgically implanted in the knee joint following removal of damaged meniscal cartilage. It was approved for patients with medial meniscus injuries.
According to its manufacturer, ReGen Biologics of Hackensack, N.J., the product is intended to provide a scaffold for new meniscal tissue to grow.
How Do I Prevent, Treat Tendonitis? Watch Video
Returning to Sports After an ACL Injury? Watch Video
How Do I Prevent ACL Reinjury? Watch Video
The FDA said this is different from other approved knee implants then on the market, which merely provided replacement or support for damaged tissue.
"Instead of simply repairing or reinforcing damaged tissue like predicate devices, Menaflex is intended to stimulate the growth of new tissue to replace tissue that was surgically removed. Because of these differences, the Menaflex device should not have been cleared by the agency," according to the FDA.
Before beginning the revocation process, the FDA indicated, it would seek a meeting with ReGen officials to discuss the appropriate marketing pathway for the device and what data it would need to provide a reasonable assurance of safety and effectiveness.
The company could theoretically get the product cleared again by going through the premarket approval (PMA) process, which is more stringent than the 510(k) pathway.
The latter process requires only that a product sponsor demonstrate that its device is "substantially equivalent" to one or more products already cleared for marketing. First-in-class products require a PMA, for which full efficacy and safety trials must be conducted.
ReGen issued a statement indicating that "the company is currently weighing its options." It also asserted that "there has never been a safety issue" with the product.
In justifying its decision to yank Menaflex's 510(k) clearance, the FDA cited findings from its internal investigation that were released in September 2009, indicating that "external pressures" had affected the product's review.
The investigators found evidence that ReGen had lobbied the FDA's commissioner in 2008, Dr. Andrew von Eschenbach, on behalf of Menaflex, such that he became "personally engaged in the details of a process usually coordinated at the Center level."
According to their report, von Eschenbach ordered the CDRH's director at the time, Dr. Daniel Schultz, to convene a review panel meeting for Menaflex on short notice, the result being that several experienced members could not attend and materials were made available one week before the meeting instead of the usual three to five weeks.
The report also noted that the commissioner showed "unusual interest in the composition of the panel," asking to see their resumes, and "pressed the Center to issue a decision" shortly after the panel's November meeting, as did the company.
The center's staff had initially determined that Menaflex was not substantially equivalent to existing approved devices and hence ineligible for 510(k) approval. But Schultz ordered a reconsideration of that determination, which was subsequently reversed.
Under pressure from ReGen, staff who had participated in the original negative review were not allowed to speak at the panel meeting, the investigation found.
How Do I Prevent, Treat Tendonitis? Watch Video
Returning to Sports After an ACL Injury? Watch Video
How Do I Prevent ACL Reinjury? Watch Video
The report also indicated that Schultz allowed the final clearance to include approval for acute as well as chronic meniscal injuries in accordance with documents submitted by the company, even though it had previously agreed to limit the requested indication to chronic injuries only.
Schultz resigned in August 2009 following allegations from some CDRH professional staff that they had been pressured by senior officials to reverse negative device evaluations.
In deciding to revoke Menaflex's clearance, the FDA also relied on input from its Orthopedic Devices Advisory Committee, which met this past March to review the scientific data on the product.
The panel expressed few concerns about the product's safety, but indicated that the evidence for its effectiveness fell short in some areas.
The MV at the recent high $0.01 is just $97K which is still joke low as a hot bio-tech company or as a clean RM shell.
Note, the available float for trading is less than 1M shares which is super tiny.
The cash value is $2.47M or $0.25 per share.
The revenue is $1.5M or $0.22 per share.
The gross profit is $681K.
The enterprise value is $6,360,000 or $0.6504 per share.
The insiders ownership is 0.6% of OS.
Key technical updating: The 20/50/200-Day MAL is 0.0008/0.0007/0.0011.
Note, The three-year high was $0.35.
The company website: http://www.ivysportsmed.com/
ReGen Biologics, Inc. (RGBOQ) Business Summary:
ReGen Biologics, Inc. designs, develops, manufactures, and markets medical devices for the repair and generation of soft tissue in humans, primarily for orthopedic applications. The company's proprietary collagen matrix technology includes applications in orthopedics, general surgery, spine, cardiovascular, and drug delivery. Its products include Menaflex collagen meniscus implant device, for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus; and SharpShooter Tissue Repair System, an instrument that allows surgeons to place needles in hard-to-reach locations of the meniscus. The company sells its products in the United States, the European Union, the Republic of South Africa, Canada, Australia, Chile, and Japan. ReGen Biologics, Inc. was founded in 1987 and is headquartered in Hackensack, New Jersey.
There are fifteen full-time employees with the company.
ReGen Biologics Inc. (PINK:RGBO) filed for Chapter 11 bankruptcy protection with the U.S. Bankruptcy Court for the District of Delaware.
April 11, 2011 by MassDevice staff
Embattled ReGen Biologics Inc. files voluntary petitions for Chapter 11 bankruptcy protection and announces a $1 million private placement from one of its largest investors.
The embattled maker of the Menaflex knee implant said in regulatory filings that the bankruptcy petition includes the company's wholly-owned subsidiary RBio Inc., but not its wholly-owned Swiss subsidiary, ReGen Biologics AG. The company will use cash flow from operations and proceeds from a loan it received from one of its largest institutional shareholders to pay the bills while it goes through the bankruptcy process.
ReGen said it raised $1 million through a private placement deal with the Sports Medicine Holding Company LLC, a division of Ivy Healthcare Capital II L.P., one of its largest shareholders. The private placement comes in the form of senior secured notes due August 31, which carry a 12 percent annual interest rate.
The bankruptcy filing adds yet another layer to the ReGen story, featuring a protracted and public battle with the FDA for nearly two years that has captured the attention of the medical device industry. Last week, the FDA rescinded its 2008 510(k) clearance of the Menaflex device, a bio-absorbable mesh implant designed to encourage the re-growth of damaged knee cartilage. The rescission means Hackensack, N.J.-based ReGen has to keep the device off the U.S. market until it can prove its safety and effectiveness to the FDA's satisfaction.
ReGen wasn't shy about voicing its displeasure over the rescission, with CEO Gerald Bisbee calling it "totally unbelievable."
The FDA said it wants ReGen to "discuss the appropriate marketing pathway for the device and what data it would need to provide a reasonable assurance of safety and effectiveness," five years after the company began the 510(k) application process.
ReGen has sunk $30 million into meeting requirements set by the FDA's Center for Devices & Radiological Health, according to Bisbee, "only to have the agency reverse decisions made by previous CDRH officials by stating that they were in error with no substantial evidence that is true."
The Menaflex 510(k) clearance in December 2008 came over the objections of FDA scientists who opposed clearing the device. In September 2009 the agency admitted that undue influence from four New Jersey congressmen and former commissioner Andrew von Eschenbach affected the decision to green-light the device and announced an investigation into the foofaraw.
In March, the agency's Orthopedic & Rehabilitation Devices Panel decided that, while the implant is reasonably safe, its effectiveness needed to be further analyzed. That decision came the same week that the FDA released a report saying ReGen failed to produce adequate evidence that device was safe before it was cleared to hit the market.
"It's unbelievable that after more than five years of 510(k) review of this product — and after being told by the ODE Director and the CDRH Director to file two separate 510(k) submissions for this device as a surgical mesh — [CDRH head Dr. Jeffrey] Shuren now says that they were wrong," Bisbee said in prepared remarks on March 22. "This arbitrary and unsubstantiated intention is an example of why the investment community is increasingly wary of investing in companies with products requiring FDA approval."
That wasn't the only shot Bisbee fired across the FDA's bow.
"We and they both know the agency has no legal authority to rescind its clearance of Menaflex. There is ample evidence the FDA completely botched its review of our Collagen Scaffold at every stage," he said. "After six years of unthinkable bias, mistakes and blunders, we are opting out of the FDA's administrative process and pursuing other legal options for continuing to market Menaflex to U.S. orthopedic surgeons and their patients."
FDA Will Rescind Approval of Knee Implant Device
By JOHN GEVER, MedPage Today Senior Editor
Oct. 15, 2010
WASHINGTON -- The U.S. Food and Drug Administration said it should not have approved a collagen-based knee implant called Menaflex under the 510(k) process and will seek to revoke the product's clearance after meeting with its manufacturer.
The product, cleared by the FDA's Center for Devices and Radiological Health in December 2008, came under fire a few months later when the FDA -- then under new leadership -- announced an internal investigation into the approval process for Menaflex. A parallel inquiry began in Congress at the same time.
The FDA has now concluded that the 510(k) process was inappropriate in this case because Menaflex "is intended to be used for different purposes and is technologically dissimilar from devices already on the market."
Read this story on www.medpagetoday.com.
It also cited findings from its internal investigation suggesting that "external pressures" had influenced the device's review.
Menaflex is a crescent-shaped piece of resorbable collagen-based material that is surgically implanted in the knee joint following removal of damaged meniscal cartilage. It was approved for patients with medial meniscus injuries.
According to its manufacturer, ReGen Biologics of Hackensack, N.J., the product is intended to provide a scaffold for new meniscal tissue to grow.
How Do I Prevent, Treat Tendonitis? Watch Video
Returning to Sports After an ACL Injury? Watch Video
How Do I Prevent ACL Reinjury? Watch Video
The FDA said this is different from other approved knee implants then on the market, which merely provided replacement or support for damaged tissue.
"Instead of simply repairing or reinforcing damaged tissue like predicate devices, Menaflex is intended to stimulate the growth of new tissue to replace tissue that was surgically removed. Because of these differences, the Menaflex device should not have been cleared by the agency," according to the FDA.
Before beginning the revocation process, the FDA indicated, it would seek a meeting with ReGen officials to discuss the appropriate marketing pathway for the device and what data it would need to provide a reasonable assurance of safety and effectiveness.
The company could theoretically get the product cleared again by going through the premarket approval (PMA) process, which is more stringent than the 510(k) pathway.
The latter process requires only that a product sponsor demonstrate that its device is "substantially equivalent" to one or more products already cleared for marketing. First-in-class products require a PMA, for which full efficacy and safety trials must be conducted.
ReGen issued a statement indicating that "the company is currently weighing its options." It also asserted that "there has never been a safety issue" with the product.
In justifying its decision to yank Menaflex's 510(k) clearance, the FDA cited findings from its internal investigation that were released in September 2009, indicating that "external pressures" had affected the product's review.
The investigators found evidence that ReGen had lobbied the FDA's commissioner in 2008, Dr. Andrew von Eschenbach, on behalf of Menaflex, such that he became "personally engaged in the details of a process usually coordinated at the Center level."
According to their report, von Eschenbach ordered the CDRH's director at the time, Dr. Daniel Schultz, to convene a review panel meeting for Menaflex on short notice, the result being that several experienced members could not attend and materials were made available one week before the meeting instead of the usual three to five weeks.
The report also noted that the commissioner showed "unusual interest in the composition of the panel," asking to see their resumes, and "pressed the Center to issue a decision" shortly after the panel's November meeting, as did the company.
The center's staff had initially determined that Menaflex was not substantially equivalent to existing approved devices and hence ineligible for 510(k) approval. But Schultz ordered a reconsideration of that determination, which was subsequently reversed.
Under pressure from ReGen, staff who had participated in the original negative review were not allowed to speak at the panel meeting, the investigation found.
How Do I Prevent, Treat Tendonitis? Watch Video
Returning to Sports After an ACL Injury? Watch Video
How Do I Prevent ACL Reinjury? Watch Video
The report also indicated that Schultz allowed the final clearance to include approval for acute as well as chronic meniscal injuries in accordance with documents submitted by the company, even though it had previously agreed to limit the requested indication to chronic injuries only.
Schultz resigned in August 2009 following allegations from some CDRH professional staff that they had been pressured by senior officials to reverse negative device evaluations.
In deciding to revoke Menaflex's clearance, the FDA also relied on input from its Orthopedic Devices Advisory Committee, which met this past March to review the scientific data on the product.
The panel expressed few concerns about the product's safety, but indicated that the evidence for its effectiveness fell short in some areas.
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