UC Santa Barbara chemistry professor Galen Stucky has been honored for his role in the development of a blood-clotting gauze that is helping save soldiers who suffer severe, life-threatening injuries in Iraq and Afghanistan. The Department of Defense’s Advanced Technology Applications for Combat Casualty Care Award was presented to Stucky Aug. 11 during the opening ceremonies of the group’s annual meeting in Florida. The ATACCC convention is the premier scientific meeting on the battlefield medical needs of the nation's soldiers and on recent advances in trauma surgery and medicine. “I am very honored,” said Stucky of the ATACCC award. “In retrospect, this project has meant more to me than any other that I’ve worked on for the past 40 years. The most important aspect of this work is the thought that it is providing life support that is needed on an immediate-response basis to both military and civilian personnel. For those who knowingly are in harm’s way, it is particularly important.”Stucky and his colleagues were asked by the Office of Naval Research to work with Connecticut-based Z-Medica to improve its zeolite-based substance, QuikClot brand hemostatic agent, which promotes instant clotting and sealing of the wound until the injured can be taken to medical facilities. Adding to the task, the Navy wanted a solution within six months.Stucky said the next step is developing ways to stop internal bleeding. Imagine a successful, blood-borne process that would stem bleeding, say, in the case of a concussion. He and his team are planning to put their efforts into a new research project to tackle the problem.
Wednesday, August 13, 2008
Gen II Quikclot Developer gets award and eyes surgical arena
UC Santa Barbara chemistry professor Galen Stucky has been honored for his role in the development of a blood-clotting gauze that is helping save soldiers who suffer severe, life-threatening injuries in Iraq and Afghanistan. The Department of Defense’s Advanced Technology Applications for Combat Casualty Care Award was presented to Stucky Aug. 11 during the opening ceremonies of the group’s annual meeting in Florida. The ATACCC convention is the premier scientific meeting on the battlefield medical needs of the nation's soldiers and on recent advances in trauma surgery and medicine. “I am very honored,” said Stucky of the ATACCC award. “In retrospect, this project has meant more to me than any other that I’ve worked on for the past 40 years. The most important aspect of this work is the thought that it is providing life support that is needed on an immediate-response basis to both military and civilian personnel. For those who knowingly are in harm’s way, it is particularly important.”Stucky and his colleagues were asked by the Office of Naval Research to work with Connecticut-based Z-Medica to improve its zeolite-based substance, QuikClot brand hemostatic agent, which promotes instant clotting and sealing of the wound until the injured can be taken to medical facilities. Adding to the task, the Navy wanted a solution within six months.Stucky said the next step is developing ways to stop internal bleeding. Imagine a successful, blood-borne process that would stem bleeding, say, in the case of a concussion. He and his team are planning to put their efforts into a new research project to tackle the problem.
Tuesday, August 12, 2008
Ethicon Endo-Surgery Acquires SurgRx
Representatives of Ethicon Endo-Surgery said today that the company is acquiring SurgRx, which develops the bipolar tissue sealing system used in the EnSeal device line.
"The acquisition has the potential to expand the global availability of the EnSeal product line," Rodney Perkins MD, SurgRx chairman, said in a statement.
The acquisition gives Johnson & Johnson subsidiary Ethicon Endo-Surgery a new platform to complement its Harmonic line of ultrasonic medical devices. These devices are used to perform open and laparoscopic procedures.
Redwood City, Calif.-based SurgRx was founded in 2002 and manufactures EnSeal, which combines high compression and controlled energy delivery to quickly create strong vessel seals. The EnSeal device, cleared by the FDA in 2003, is capable of sealing vessels up to 7mm in diameter.
Ethicon develops devices for minimally invasive and open surgical procedures with a focus on interventional diagnosis in gastrointestinal health, bariatric surgery and general surgery.
Terms of the agreement were not disclosed.
Ethicon Endo-Surgery and SurgRx share a commitment to innovation, according to Karen Licitra, company group chairman and worldwide franchise chairman for Ethicon Endo-Surgery.
"Together, the combination of Harmonic and EnSeal technologies will position us to better address many different procedure needs," she said in a statement.
"The acquisition has the potential to expand the global availability of the EnSeal product line," Rodney Perkins MD, SurgRx chairman, said in a statement.
The acquisition gives Johnson & Johnson subsidiary Ethicon Endo-Surgery a new platform to complement its Harmonic line of ultrasonic medical devices. These devices are used to perform open and laparoscopic procedures.
Redwood City, Calif.-based SurgRx was founded in 2002 and manufactures EnSeal, which combines high compression and controlled energy delivery to quickly create strong vessel seals. The EnSeal device, cleared by the FDA in 2003, is capable of sealing vessels up to 7mm in diameter.
Ethicon develops devices for minimally invasive and open surgical procedures with a focus on interventional diagnosis in gastrointestinal health, bariatric surgery and general surgery.
Terms of the agreement were not disclosed.
Ethicon Endo-Surgery and SurgRx share a commitment to innovation, according to Karen Licitra, company group chairman and worldwide franchise chairman for Ethicon Endo-Surgery.
"Together, the combination of Harmonic and EnSeal technologies will position us to better address many different procedure needs," she said in a statement.
Monday, August 11, 2008
Omrix Ethicon - We're number 2 in Thrombin
During Omrix Q2 discussion was made on Evicel, Quixil, Evithrom, the Fibrin pad and a mystery bonus product that was just icing on the earnings cake. Revenue was up 72% year over year, led by Johnson & Johnson's Ethicon's 155% jump in sales of Omrix's biosurgical products. Most of that likely came from improved sales of Evicel -- its fibrin sealant used to stop surgical bleeding. The product was approved for use in all surgeries earlier. CEO Taub stated the obvious for the thrombin market "I'll rank the three competitors, King one, Ethicon/Omrix two and ZymoGenetics three."
On Ethicon intiatives with Evicel:
“a focus on burns and orthopedics and plastic surgery”
“an updated evicel website”
On Quixil:
“growing nicely” in Europe especially in Orthopedics.
On Evithrom:
continued “moderate growth” approx. 40% of purchasers were first time buyers.
On Fibrin Pad trials in Israel and USA:
ongoing but on target
anticipating approval first half 2010
On major costs:
Plasma costs expected to rise
On the “mystery” $ 1.9 million contributing by-product of Omrix plasma preparation:
It is an imuno-therapy product not a biosurgical
A 3 year contract is in place to continue selling these previously discarded by-products
The product is used on humans
Contractually unable to release name or country of partner
On Ethicon intiatives with Evicel:
“a focus on burns and orthopedics and plastic surgery”
“an updated evicel website”On Quixil:
“growing nicely” in Europe especially in Orthopedics.
On Evithrom:
continued “moderate growth” approx. 40% of purchasers were first time buyers.On Fibrin Pad trials in Israel and USA:
ongoing but on target
anticipating approval first half 2010
On major costs:Plasma costs expected to rise
On the “mystery” $ 1.9 million contributing by-product of Omrix plasma preparation:
It is an imuno-therapy product not a biosurgical
A 3 year contract is in place to continue selling these previously discarded by-products
The product is used on humans
Contractually unable to release name or country of partner
HemCon Bandages Receive Expanded Indications for Antibacterial Barrier, Including MRSA
The Centers for Disease Control and Prevention (CDC) estimates that 1.7 million hospital patients acquire infections each year, and 103,000 die as a result. HemCon Medical Technologies Inc., a leading global medical products company focused on advanced wound care innovations, today announced new antibacterial indications by the FDA, including a barrier against MRSA, for its HemCon® Bandages, ChitoFlex® dressings and KytoStat® Bandages.
The hemostatic HemCon Bandage and ChitoFlex dressing are now approved with an antibacterial barrier indication against a wide range of harmful organisms, including the antibiotic-resistant staphylococcus aureus (MRSA), enterococcus faecalis (VRE) and acinetobacter baumannii.
Hospital-acquired infections have a significant impact on patients and health care facilities. An estimated 2.6 percent of nearly 30 million operations are complicated by surgical site infections each year according to the Institute for Healthcare Improvement. The Center for Medicare and Medicaid Services will no longer pay hospitals for additional costs associated with treating patients for certain hospital-acquired infections and medical errors. Hospital-acquired infections add an estimated $30.5 billion annually to the nation’s health care costs.
“HemCon hemostatic bandages and dressings provide an effective way to decrease the risk of infection at wound sites. Concurrently, the bandages also provide health care professionals with a viable hemostatic solution that can advance the standard of care,” said John W. Morgan, president and CEO of HemCon Medical Technologies. “This is a great step forward in improving patient care and outcomes.”
HemCon’s bandages, created from a natural substance in shrimp shells called chitosan, stop bleeding – including extensive arterial bleeding – within two to five minutes. The antibacterial barrier properties of the bandages help prevent infection transmission to other patients and health care providers and also make it easier for medical professionals to help prevent infections at incision site wounds. This potentially decreases patient complications and length of hospital stay.
HemCon dressings control bleeding by becoming extremely adherent when in contact with blood. The adhesive-like action seals the wound and attracts red blood cells to the bandage, forming a seal that stops hemorrhaging independent of the body’s natural clotting process. The bandages and dressings provide a barrier against harmful bacteria naturally because when in contact with the bacteria, the chitosan ruptures the cell walls of gram negative bacteria and prohibits reproduction.
The hemostatic HemCon Bandage and ChitoFlex dressing are now approved with an antibacterial barrier indication against a wide range of harmful organisms, including the antibiotic-resistant staphylococcus aureus (MRSA), enterococcus faecalis (VRE) and acinetobacter baumannii.
Hospital-acquired infections have a significant impact on patients and health care facilities. An estimated 2.6 percent of nearly 30 million operations are complicated by surgical site infections each year according to the Institute for Healthcare Improvement. The Center for Medicare and Medicaid Services will no longer pay hospitals for additional costs associated with treating patients for certain hospital-acquired infections and medical errors. Hospital-acquired infections add an estimated $30.5 billion annually to the nation’s health care costs.“HemCon hemostatic bandages and dressings provide an effective way to decrease the risk of infection at wound sites. Concurrently, the bandages also provide health care professionals with a viable hemostatic solution that can advance the standard of care,” said John W. Morgan, president and CEO of HemCon Medical Technologies. “This is a great step forward in improving patient care and outcomes.”
HemCon’s bandages, created from a natural substance in shrimp shells called chitosan, stop bleeding – including extensive arterial bleeding – within two to five minutes. The antibacterial barrier properties of the bandages help prevent infection transmission to other patients and health care providers and also make it easier for medical professionals to help prevent infections at incision site wounds. This potentially decreases patient complications and length of hospital stay.
HemCon dressings control bleeding by becoming extremely adherent when in contact with blood. The adhesive-like action seals the wound and attracts red blood cells to the bandage, forming a seal that stops hemorrhaging independent of the body’s natural clotting process. The bandages and dressings provide a barrier against harmful bacteria naturally because when in contact with the bacteria, the chitosan ruptures the cell walls of gram negative bacteria and prohibits reproduction.
Thursday, August 7, 2008
Orthovita Q2
Sales growth for the reported periods in 2008 was primarily attributable to increased sales of our VITOSS(R) FOAM and VITAGEL(R) product portfolios in the U.S. as we further develop our U.S. field sales network. Approximately 60% of our product sales during the three and six months ended June 30, 2008 and 2007, respectively, were from products based upon our VITOSS FOAM platform co-developed with Kensey Nash Corporation. VITAGEL contributed approximately 25% of product sales for the three and six months ended June 30, 2008, as compared to approximately 19% and 20% of our product sales during the three and six months ended June 30, 2007, respectively.
King Pharmaceuticals shares dive after 2Q report
Shares of King Pharmaceuticals Inc. tumbled Thursday after the specialty drugmaker issued a disappointing second-quarter earnings report. King Pharmaceuticals has reported it saw a drop in revenue in the second quarter of the year.Total revenues for April to June were $397 million, compared with $543 million in the same period last year.King said the main reason for its decreased revenue was the arrival to the market of generic substitutes for its Altace drug.
However, Brian Markison, chairman, president and chief executive officer of King, said the firm is pleased with the continued strong
performance of its Thrombin-JMI drug.
When asked for more detail on pricing and background on the thrombin market they again reiterated the perception of an "account by account fight" with a "fair amount of pressure on pricing". There was also a "a lot of pressure on the margin".
However, Brian Markison, chairman, president and chief executive officer of King, said the firm is pleased with the continued strong
performance of its Thrombin-JMI drug.When asked for more detail on pricing and background on the thrombin market they again reiterated the perception of an "account by account fight" with a "fair amount of pressure on pricing". There was also a "a lot of pressure on the margin".
Tuesday, August 5, 2008
Thrombin - Recothrom Q2 sales
Bruce L.A. Carter, Ph.D., CEO of ZymoGenetics highlighted the laborious process of attaining hospital approval for the product "First, we have to enlist the support of surgeons, nurses, and pharmacists. Then we have to get RECOTHROM on the agenda for upcoming pharmacy and therapeutics committee meetings. Then we need to get the P&T committee to endorse RECOTHROM either as the addition to the formulary or a commitment to completely convert to RECOTHROM. Then we have to work with hospital pharmacists and surgical departments to process conversions and circle back to surgeons and nurses to encourage the use of RECOTHROM...........Of the 169 meetings that have taken place as of late June, decisions were made at a 103 meetings, with 66 where decision was still pending. Of the 103 meetings with decisions, 77 approved either complete conversion to 
RECOTHROM from bovine, or addition of RECOTHROM. 26 P&T committees declined to add RECOTHROM at this time, but many of those of course occurred before the GPO pricing agreements were in place, and before we had a full line of products.
So we need to circle back and get more surgeons at these hospitals. So through late June, the decisions were; 30% to completely convert so RECOTHROM is the only approved product, 45% of the time to add, and 25% to decline at this time.
As of mid-July, a 130 hospitals have now purchased RECOTHROM, and we are pleased to say that approximately 60% have reordered, and a third are already doing so on a routine basis.
So to reiterate; RECOTHROM is being well received by surgeons consistent with our expectations, and I think this is evidenced by a 75% positive response from decisions made to-date. The selling process in this market is long, and in some cases it is taking longer than we anticipated. We have put GPO contracts covering a large portion of the marketing place, and we now have a full line of RECOTHROM product, which will help build sales in the second half of the year, and we are confident that RECOTHROM will become the market leader in the coming years, and that our commercialization strategy is sound."
Bruce also discussed Zymo’s interpretation of the hospitals consideration in terms of facing a coagulation issues and also the threat of possible complications due bovine thrombin. Discussing price sensitivity he asserted that while not fully aware of the cost involved with Thrombin JMI, Recothrom was unlikely to be produced as cheaply as King Pharmaceuticals bovine Thrombin JMI but Omrix manufactured (Ethicon distributed) human sourced Evithrom was likely to be associated with higher costs. Bruce said "I don’t know the precise cost associated with the production of bovine thrombin -- but I would guess that it would be difficult for us to match the cost of goods of bovine thrombin. However, the other, when it comes to human thrombin in collecting plasma from humans, then I think that's a different issue. That's going to much, much more expensive." I guess Ethicon negative publicity for King's bovine product will work to Zymo's advantage...........
RECOTHROM from bovine, or addition of RECOTHROM. 26 P&T committees declined to add RECOTHROM at this time, but many of those of course occurred before the GPO pricing agreements were in place, and before we had a full line of products.So we need to circle back and get more surgeons at these hospitals. So through late June, the decisions were; 30% to completely convert so RECOTHROM is the only approved product, 45% of the time to add, and 25% to decline at this time.
As of mid-July, a 130 hospitals have now purchased RECOTHROM, and we are pleased to say that approximately 60% have reordered, and a third are already doing so on a routine basis.
So to reiterate; RECOTHROM is being well received by surgeons consistent with our expectations, and I think this is evidenced by a 75% positive response from decisions made to-date. The selling process in this market is long, and in some cases it is taking longer than we anticipated. We have put GPO contracts covering a large portion of the marketing place, and we now have a full line of RECOTHROM product, which will help build sales in the second half of the year, and we are confident that RECOTHROM will become the market leader in the coming years, and that our commercialization strategy is sound."
Bruce also discussed Zymo’s interpretation of the hospitals consideration in terms of facing a coagulation issues and also the threat of possible complications due bovine thrombin. Discussing price sensitivity he asserted that while not fully aware of the cost involved with Thrombin JMI, Recothrom was unlikely to be produced as cheaply as King Pharmaceuticals bovine Thrombin JMI but Omrix manufactured (Ethicon distributed) human sourced Evithrom was likely to be associated with higher costs. Bruce said "I don’t know the precise cost associated with the production of bovine thrombin -- but I would guess that it would be difficult for us to match the cost of goods of bovine thrombin. However, the other, when it comes to human thrombin in collecting plasma from humans, then I think that's a different issue. That's going to much, much more expensive." I guess Ethicon negative publicity for King's bovine product will work to Zymo's advantage...........
Interestingly many of us expected hospitals to use bovine (King), human (ethicon/Omrix) or Zymo (Recothrom)............but when queried....by Kevin DeGeeter - Oppenheimer
"Okay. And maybe two more quick questions if I may. It looks like we continue to see about 45% of these P&T committees leaving bovine on formulary base, quite putting both products on formulary, which I think is very different than what everyone was expecting previous to launch. I think we expected hospital either be bovine, human, or recombinant. First, I guess, just answer that the way which you think about the overall market, or is there something different in these early adopters that may suggest they have a different attitude towards single product on formulary versus multiple? And if it's going to be half the market, give or take, it's going to have multiple products on formulary. How does that change the sales message here?"
Bruce Carter
"I think that what we believe, as you're seeing, is that some people fully convert. Others, and I don't think it's at all surprising, say, look, you guys are new. We'd like to put you on the formulary. We're going to try you out on the formulary. We want to make sure that you can consistently supply us, so we don't want to remove the other product. So we feel comfortable that you can consistently supply us. And we believe that over a matter of time, people will convert to just one, and we believe that will be RECOTHROM.
As we've said before, we see this as a ratchet mechanism. In addition, of course, remember that a number of these people are putting us on the formulation time when we didn't have the full complement, we didn't have the 20000-unit, we didn't have the spray. So they would feel that converting completely to RECOTHROM was not appropriate at that particular point in time. So we're not surprised. We would also, as I've said once before, expect full conversion eventually."
Sunday, August 3, 2008
Hemostasis Big Week for Results - Omrix, King, Zymo, Orthovita
It's a big week for Q2 results for the big 3 in the thrombin sector with Omrix 11th, King 7th and Zymogenetics Aug 5th.According to IMS, the market research firm, hospitals purchased $440,000 of Recothrom during June. In a research report, Kevin DeGeeter, an analyst at Oppenheimer & Co., said he forecast sales would be $750,000 for the month. DeGeeter said that stockpiling by wholesalers (which is not counted in the IMS numbers) should "largely offset weak user demand" by hospitals. He expects second-quarter Recothrom sales to be only slightly below his initial estimate of $3.3 million.
Orthovita will also hold a conference call on Thursday, August 7, 2008, at 8:30 a.m. Eastern Time, to review and discuss its financial results for the second quarter 2008. Antony Koblish, President and Chief Executive Officer, and Albert J. Pavucek, Jr., Chief Financial Officer of Orthovita, will host the call.
Friday, August 1, 2008
Cryolife Q2 Biofoam and Hemostase MPH
CryoLife, Inc. (NYSE: CRY), a biomaterials, medical device and tissue processing company, announced today that revenues for the second quarter of 2008 increased 18 percent to $27.2
million compared to $23.0 million in the second quarter of 2007.
During the Cryolife Q2 results mention was made of Biofoam which is being made with the help and funding of the Dept. of Defense (DOD). Biofoam is an expandable version of bioglue which expands to about 4 times its size as it leaves the syringe. BioFoam® Surgical Sealant (BioFoam) is a two-component surgical sealant composed of purified bovine serum albumin (BSA) solution with sodium bicarbonate and glutaraldehyde solution with acetic acid. The two components of BioFoam are contained in a dual chambered syringe and, at the point of delivery, are mixed in a specially designed applicator tip. Indications are for both Trauma and Surgical use. It appears suited to abdominal resections or lacerations and is ready to commence filing for regulatory submission. CE submission is planned for November 2008 and approval is expected late in Q1 2009 and product launch is expected 2-3 months after that, FDA IDE submission is planned for Q4 2008.
Sales of Hemostase MPH licensed from Medafor in early May have been "encouraging" and contributed $320,000 in the first 3 months including most of July. Steven G. Anderson, president and chief executive officer stated that internationally Hemostase MPH has had some success in the UK and Germany with launches in France and Canada set for September 1. Distribution throughout the rest of Europe, the America's, Australia and Asia-Pacific is scheduled for January 1 2009.
Analyst Matt Dolan enquired how long the sales force had sufficient product quantities to commence sales and was told orders only commenced in mid May but the US sales team now had full access to product. Cryolife also said new accounts and re-order rates are moving well for Hemostase MPH.
BioGlue(R) Surgical Adhesive revenues were $13.0 million for the second quarter of 2008 compared to $10.9 million in the second quarter of 2007, an increase of 19 percent. BioGlue revenues were $24.9 million for the first six months of 2008 compared to $22.1 million in the first six months of 2007, an increase of 13 percent.
U.S. BioGlue revenues were $9.1 million and $7.7 million in the second quarter of 2008 and 2007, respectively. U.S. BioGlue revenues were $17.7 million and $16.0 million in the first six months of 2008 and 2007, respectively. International BioGlue revenues were $3.9 million and $3.2 million in the second quarter of 2008 and 2007, respectively. International BioGlue revenues were $7.2 million and $6.1 million in the first six months of 2008 and 2007, respectively.
Other implantable medical device revenues for the second quarter of 2008 were $308,000, compared to $226,000 in the second quarter of 2007. Other implantable medical device revenues for the first six months of 2008 were $401,000 compared to $458,000 in the first six months of 2007. Other implantable medical device revenues in the second quarter and first six months of 2008 included $177,000 for Hemostase MPH(R), which was added to the CryoLife product portfolio in the second quarter of 2008.
million compared to $23.0 million in the second quarter of 2007.
During the Cryolife Q2 results mention was made of Biofoam which is being made with the help and funding of the Dept. of Defense (DOD). Biofoam is an expandable version of bioglue which expands to about 4 times its size as it leaves the syringe. BioFoam® Surgical Sealant (BioFoam) is a two-component surgical sealant composed of purified bovine serum albumin (BSA) solution with sodium bicarbonate and glutaraldehyde solution with acetic acid. The two components of BioFoam are contained in a dual chambered syringe and, at the point of delivery, are mixed in a specially designed applicator tip. Indications are for both Trauma and Surgical use. It appears suited to abdominal resections or lacerations and is ready to commence filing for regulatory submission. CE submission is planned for November 2008 and approval is expected late in Q1 2009 and product launch is expected 2-3 months after that, FDA IDE submission is planned for Q4 2008.
Sales of Hemostase MPH licensed from Medafor in early May have been "encouraging" and contributed $320,000 in the first 3 months including most of July. Steven G. Anderson, president and chief executive officer stated that internationally Hemostase MPH has had some success in the UK and Germany with launches in France and Canada set for September 1. Distribution throughout the rest of Europe, the America's, Australia and Asia-Pacific is scheduled for January 1 2009.Analyst Matt Dolan enquired how long the sales force had sufficient product quantities to commence sales and was told orders only commenced in mid May but the US sales team now had full access to product. Cryolife also said new accounts and re-order rates are moving well for Hemostase MPH.
BioGlue(R) Surgical Adhesive revenues were $13.0 million for the second quarter of 2008 compared to $10.9 million in the second quarter of 2007, an increase of 19 percent. BioGlue revenues were $24.9 million for the first six months of 2008 compared to $22.1 million in the first six months of 2007, an increase of 13 percent.
U.S. BioGlue revenues were $9.1 million and $7.7 million in the second quarter of 2008 and 2007, respectively. U.S. BioGlue revenues were $17.7 million and $16.0 million in the first six months of 2008 and 2007, respectively. International BioGlue revenues were $3.9 million and $3.2 million in the second quarter of 2008 and 2007, respectively. International BioGlue revenues were $7.2 million and $6.1 million in the first six months of 2008 and 2007, respectively.Other implantable medical device revenues for the second quarter of 2008 were $308,000, compared to $226,000 in the second quarter of 2007. Other implantable medical device revenues for the first six months of 2008 were $401,000 compared to $458,000 in the first six months of 2007. Other implantable medical device revenues in the second quarter and first six months of 2008 included $177,000 for Hemostase MPH(R), which was added to the CryoLife product portfolio in the second quarter of 2008.
Thursday, July 31, 2008
CSMG Technologies Announces U.S. FDA 510(k) Clearance for Live Tissue Connect’s VAD System
CSMG Technologies, Inc., (OTCBB: CTGI), a technology management company, announced its subsidiary Live Tissue Connect, Inc. (LTC) received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its LTC VAD System. The LTC VAD System consists of a LTC VAD.400 bipolar electrosurgical generator and two disposable sealing instruments. FDA clearance allows LTC to market these products in the USA.
The VAD.400 generator and the two disposable instruments are intended for use in open general surgical and gynecological procedures for the ligation of vessels and ducts as an alternative to mechanical clamping (clips or staples) and suturing. LTC’s new third generation bipolar system can be used on vessels (veins and arteries) up to 7 mm diameter, on ducts up to 2 mm diameter and tissue bundles as large as will fit in the jaw electrodes of the instruments.
Donald S. Robbins, President and CEO of CSMG Technologies, said, "I am very pleased for our shareholders to be able to announce the most important and long awaited event in the history of LTC. By LTC receiving its first U.S. FDA 510(k) on the generator and the two instruments they are now able to start marketing in the U.S. market. I wish to publicly congratulate all the medical device professions involved with the LTC technology and the LTC team in Santa Barbara, California. I also want to personally thank as well all the CSMG shareholders who have believed in our potential and stayed the course waiting for this key corporate event."
Frank D. D’Amelio, President of LTC said, “The 510(k) clearance of our generator and disposable instruments marks the completion of a major milestone for LTC. The technology embodied within the VAD.400 generator and the interconnecting disposable instruments represents years of scientific research regarding the effects of RF energy on tissue. The LTC bipolar system has undergone extensive animal clinical testing; has been the subject to numerous peer-reviewed papers; and has passed all applicable quality standards. Having now obtained this clearance, we will next implement our USA sales representative recruitment plan and ramp up our production for distribution.”
The VAD.400 generator and the two disposable instruments are intended for use in open general surgical and gynecological procedures for the ligation of vessels and ducts as an alternative to mechanical clamping (clips or staples) and suturing. LTC’s new third generation bipolar system can be used on vessels (veins and arteries) up to 7 mm diameter, on ducts up to 2 mm diameter and tissue bundles as large as will fit in the jaw electrodes of the instruments.
Donald S. Robbins, President and CEO of CSMG Technologies, said, "I am very pleased for our shareholders to be able to announce the most important and long awaited event in the history of LTC. By LTC receiving its first U.S. FDA 510(k) on the generator and the two instruments they are now able to start marketing in the U.S. market. I wish to publicly congratulate all the medical device professions involved with the LTC technology and the LTC team in Santa Barbara, California. I also want to personally thank as well all the CSMG shareholders who have believed in our potential and stayed the course waiting for this key corporate event."
Frank D. D’Amelio, President of LTC said, “The 510(k) clearance of our generator and disposable instruments marks the completion of a major milestone for LTC. The technology embodied within the VAD.400 generator and the interconnecting disposable instruments represents years of scientific research regarding the effects of RF energy on tissue. The LTC bipolar system has undergone extensive animal clinical testing; has been the subject to numerous peer-reviewed papers; and has passed all applicable quality standards. Having now obtained this clearance, we will next implement our USA sales representative recruitment plan and ramp up our production for distribution.”
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