and LARRY HAIMOVITCH
BB&T Contributing Writer
SAN FRANCISCO — The deepening recession did not appear to dampen attendees' enthusiasm for the healthcare sector at the JP Morgan Healthcare Conference in mid-January, nor did it serve to thin out the usual crowds at the Westin St. Francis, which seemed to be even larger than ever. Most of the throng at this year's event gathered in the venerable hotel's Grand Ballroom to hear JP Morgan Chairman/CEO Jamie Dimon speak on a variety of topics, including healthcare policy and the current state of the economy.
Right out of the box, Dimon made an argument for the need for some form of universal healthcare in the U.S., noting the fact that there are about 47 million people in this country with no health insurance, a number that is sure to increase as the current recession continues. He argued that employing more preventive medicine would be far more cost-effective and humane than having destitute patients coming in to emergency rooms in various states of deterioration.
"I have a deep belief that it will be a far more effective country if we get this problem fixed and do it now," Dimon said. "It will be cheaper immediately and it will be cheaper in the long run and action should not be deferred because you know that costs are skyrocketing and problems don't age well."
Dimon pointed to a "window of opportunity" to get something done on the universal healthcare front with willing participants in President Barack Obama and about-to-be-approved Secretary of Health and Human Services Tom Daschle.
He noted that as a country, we're not getting much bang for our healthcare buck. The U.S. spends more than any other country in the world on healthcare, nearly 16% of our GNP goes to pay for it, and life expectancy is actually declining overall instead of increasing in the U.S.
Any new healthcare plan, Dimon said, would likely still contain elements of the prevalent employer-based system, particularly since 175 million people in this country get it that way now but he argued that as a country "we need to go beyond that," to find new solutions. He added that the current system in which healthcare insurance became linked to employment, and a tax-deductible benefit at that, was a "historical accident." Just because the system was set up this way, he argued, does not mean it needs to continue that way.
Some disadvantages of the current model Dimon said include a lack of portability when one leaves a job. He also noted that the current system is not set up to give consumers incentives to make choices that could help it become cheaper and more effective over time.
One component to any new healthcare plan that Dimon said cannot be ignored is the absolute need for universal coverage. "I believe that everyone has to be covered. If you don't cover [all] the people, they will be a burden to everyone else."
As another practical element of any new healthcare system, Dimon said that, "consumers must have skin in the game." If consumers don't demand a policy that finds the cheapest way to provide effective healthcare, he said, "We won't find the cheapest possible way."
Consumer demand for cheaper alternatives to treatment could be a boon to entrepreneurs, Dimon suggested. As an example, he cited Wal-Mart's (Bentonville, Arkansas) walk-in clinics, which he said can provide flu shots to the masses cheaper than anyone else. "There will be hundreds of innovations like this if consumers are seeking them out and you're allowed to provide them over time."
Of course one component that Dimon argued would be essential to lowering healthcare costs wouldn't cost the consumer anything, eating a healthier diet and exercising. Dimon suggested that consumers should get some sort of monetary benefit, other than the possibility of a longer life, if they follow preventative care, including getting cancer screenings and annual physicals.
On the economic front, Dimon said that a lot of people knew that things were heading south, before the actual collapse occurred. "But people didn't know about, nor do I think they should have known about, is how bad it would get." He said that the most pessimistic people thought that we would have a recession that would wipe out the excesses in the economy and we go on our merry way." Instead the problems were compounded with the primary offenders being a housing bubble and deplorable underwriting from financial institutions.
Dimon characterized the government's dedication to a hefty bailout package for financial markets as a "bold dynamic action over time." He said that while it would be very easy to criticize it, the alternatives were not very palatable. In the spirit of the healthcare conference, Dimon likened the economy to a patient who comes into the emergency room with multiple wounds and multiple lacerations and while surgeons were trying to treat life threatening bleeding, the heart suddenly stopped beating. He said that when we as a country look back at the bailout effort in a decade "I personally believe that over time, this will be looked at as an example of America acting quickly, not acting slow. The actions are starting to work, I think you're starting to see a thawing of the markets."
Oddly enough, Dimon didn't seem to think that specific groups within the healthcare industry needed any form of bailout. During a Q&A session one questioner asked whether JP Morgan would help support a biotechnology industry bailout, which the questioner said was "in cardiac arrest." Dimon reasoned that what is needed now is the financial institution bailout that will get the entire system moving again, which will be good for everybody."
As to when the economy might recover, Dimon said it would take a minimum of two quarters for things to start to turn around, and that was his optimistic answer. His "dark side scenario" envisioned an unemployment rate in this country of more than 10% and two plus years of recession.
Dimon said the recent lengthy bull market spurned a wave of over exuberance led by the drumbeat of continued unsustainable growth expectations. "I hate to tell you, you can't [always] grow like that. We need to be careful that we're not putting all this pressure on all these companies to find growth."
Any companies that think they will need funding in 2009 from the capital markets and get the opportunity to avail themselves of such monies "should take it," Dimon deadpanned, drawing laughter from the audience. He said the cost of money right now "is rather cheap," and not taking advantage of an opportunity to save a few hundred basis points could be fatal if his aforementioned doomsday scenario plays out.
Firms of all sizes make their pitch
The JP Morgan conference has something for everyone, with companies representing varying sub-sectors within the field and representing all different levels of capitalization from large-cap well-established companies to much smaller private companies still trying to make a name for themselves.
Definitely falling into the large-cap camp is Medtronic (Minneapolis), one of the largest medical technology companies in the world. Company Chairman/CEO Bill Hawkins said during his presentation that with healthcare reform on the horizon, he believes his company is poised "to be part of the solution, not the problem."
Unquestionably, the big news for the company that week was the announcement of its pending acquisition of Ablation Frontiers (AB; Carlsbad, California) for an initial payment of $225 million plus potential milestone payments.
Medtronic said the goal of its newly formed AF Solutions franchise, led by VP and general manager Reggie Groves, is to be the physician partner of choice for atrial fibrillation (AF) ablation by bringing breakthrough AF therapies to the patients and physicians that are simpler, safer, effective, and offer more predictable procedure times than current treatment methods.
Following Medtronic's recent acquisition of CryoCath Technologies (Montreal), the addition of Ablation Frontiers' anatomically designed, catheter-based ablation technologies and its unique radiofrequency (RF) energy system will allow Medtronic to deliver the industry's broadest range of therapies, the company said. Medtronic reported its intention to buy CryoCath in September for $380 million in cash.
In 2006, Ablation Frontiers received the CE mark to begin marketing its system of catheters and the RF generator in the European Union. Ablation Frontiers is conducting a clinical trial under a FDA investigational device exemption to gain approval for permanent, or chronic, AF in the U.S.
Hawkins said this latest acquisition will allow the company "to democratize the whole AF procedure." He added that the AB technology "basically obviates the need to do extensive mapping and make this procedure easier to be done by a variety of different [emergency technicians]."
Hawkins said he sees the neuromodulation space as one area that has potential for great growth in the near term, particularly with the aging population and with that increasing numbers of people with neurodegenerative diseases. Areas that the company is working in include epilepsy, Parkinson's disease, and obsessive compulsive disorder.
Hawkins also said he sees the diabetes market as another potentially large market opportunity which is "particularly underpenetrated outside the U.S." He said the company is very excited about opportunities it sees in the area of glucose monitoring. "We really are transforming this ... from being kind of a pump business to really a business of monitoring and managing the people with overall diabetes." He said the ultimate goal in this space is to "close the loop" and develop an artificial pancreas.
Representing the up-and-coming public companies was Kinetic Concepts (KCI; San Antonio), whose president/CEO, Catherine Burzik, provided a compelling argument for why investors should be excited about KCI.
KCI develops wound care and therapeutic products. Its wound care systems and therapeutic support systems address four principal clinical applications: advanced wound healing and tissue repair, pulmonary complications in the intensive care unit, bariatric care, and wound treatment.
Burzik said she sees the company's vacuum-assisted closure (V.A.C.) technology as a $6 billion market opportunity based on a current market penetration rate of about 25% of all potentially V.A.C.-able wounds. She said this number could soar to nearly $12 billion, "as we expand geographically and introduce new products."
The company plans on soon releasing a new product via its diabetic foot ulcer dressing, called the DFU Bridge Dressing. Burzik said that new dressing will be able to be used for more than just foot ulcers. She said the company plans to release new dressings annually as well as releasing a new version of the V.A.C. technology in 2010 with yet another update to the V.A.C. in the 2010 timeframe.
KCI also plans on bringing its negative wound pressure system into the surgical suite in 2009 via the SWMS product. "This is a very large opportunity aimed to both reduce the chance of infection and improve the overall cosmetic outcome from surgical wounds," said Burzik.
Moving into the future, she said the company is working on delivering the negative wound pressure subcutaneously in concert with its LifeCell (Branchburg, New Jersey) products. "This is a combination of tissue repair and tissue regeneration aimed at both soft tissue repair and hard tissue repair," that the company is calling TE Wound and TE Ortho.
On the private front, Evalve (Menlo Park, California), the promising developer of devices to enable percutaneous repair of cardiac valves made its pitch for investor attention.
Ferolyn Powell, president/CEO of the company, said that Evalve's focus is to transform an existing surgical technique into a much less-invasive percutaneous procedure, with the focus being on mitral valve regurgitation, also known as MR.
MR is the most common type of heart valve disease in the U.S. and the second most common in Europe. Since the surgical approach involves the use of a heart-lung bypass machine, a vast majority of patients elect not to undergo the procedure, which leads their hearts susceptible to chronic volume overload, and ultimately in many cases, to heart failure.
The company's MitralClip is the first commercially available system that allows for a non-surgical option for patients suffering from MR. Repair with the device is performed by physicians in the cath lab, and the heart beats normally during the procedure. Use of the device may help patients delay or avoid surgery, having also preserved the surgical options of valve repair or replacement.
Using a tiny barbed, wishbone-shaped device, the heart is fixed non-surgically from the inside out. A catheter is carefully guided through the femoral vein in the groin, up to the heart's mitral valves. The clip on the tip of a catheter is then clamped on the center of the valve leaflets, which holds them together and quickly helps restore normal blood flow out through the leaflets.
Percutaneous mitral valve regurgitation repair was cited as the fifth most important new advance in the most recent Cleveland Clinic Top 10 list of medical innovations that was unveiled in November.
Powell characterized the MR market as being over $4 billion in the U.S. alone, a figure which she said could be doubled when incorporating a worldwide market.
Powell noted that the device, which is currently approved for use in Europe, is on its way to earning a U.S. approval as well, with its recent completion of a U.S. pivotal study in 2008. She said the company expects to file its PMA submission for the MitraClip in the first half of 2010 with expected U.S. launch by the first half of 2011.
Seeking 'ayes' from investment community
While larger companies have their fans, at many investor gatherings it is the smaller private companies that really pique the interest of many investors with their potential for developing dynamic new products and, hopefully, to get in on a good thing early.
Following is a sampling of some interesting newcomers who presented at this year's JP Morgan conference.
AccessClosure (Mountain View, California), a company founded in 2002 to develop a vascular closure product for use during interventional and diagnostic procedures, was pitched by its president and CEO, Fred Khosravi.
The company's lead product, the Mynx vascular closure device, was approved by the FDA in May 2007 and since then, has been used in more than 150,000 patients. The device achieves femoral artery hemostasis via extravascular delivery of polyethylene glycol (PEG), a biomaterial commonly used in medical devices and pharmaceutical products.
Khosravi described how the product works. The water-soluable PEG mix sealant is delivered to the targeted area via a 6 Fr or 7 Fr procedural sheath. Temporary hemostasis is achieved by introducing an inter-arterial balloon, followed immediately by the mix sealant.
The non-thrombogenic sealant then instantly absorbs blood and subcutaneous fluid, rapidly expanding up to three to four times its original size inside the tissue tract and producing a durable hemostasis. The sealant dissolves within about 30 days, leaving nothing behind but a healed artery.
Since the product was approved by the FDA 18 months ago, Khosravi said that Mynx already has achieved a 12% market share in the vascular closure market. He also noted that the device is sold at an average 25% premium to existing closure devices. Khosravi attributed the product's success to a key metric that he said differentiates it from any other product on the market – that it "is 99.9% free of any major vascular complications."
Over the next 18 months, Khosravi said the company plans to introduce a 5 Fr product for use in diagnostic procedures. He said the smaller size will allow the company to further penetrate into the manual compression market.
Developing a sort of GPS system for the lungs is superDimension (Minneapolis). Its inReach system provides electromagnetic navigation and guidance to distant regions of the lungs in a minimally-invasive manner, and is designed to enable doctors to diagnose lung cancer at earlier stages and potentially provide treatment sooner.
President/CEO Daniel Sullivan called the inReach a platform technology that will allow physicians to diagnose benign and malignant lung lesions as well as mediastinal lymph nodes at much earlier stages, enabling for much early treatment decisions for a condition that has traditionally been a death sentence if detected too late.
Sullivan projected that the lung cancer market alone is close to a $7 billion opportunity. More than 1.3 million people die of lung cancer each year around the world. It is the most common cancer-related death in American men and the second most common in women, claiming more lives than breast cancer, prostate cancer and colorectal cancer combined.
He said that the detection of lung cancer at early stages when a lesion is still the size of a pencil head is critical. At that stage "if you can get to it to biopsy it and if you can get to it to treat it, your long-term survival is 90% at 10 years." However, he noted that once the cancer has metastasized to golf ball-sized dimensions, a patient's long-term survival rate plunges to "15% in five years. It's a huge swing."
The inReach provides a substantial advantage over current procedures that are used for diagnosis of lung cancer which include the introduction of a transthoracic needle that has a 30% to 50% chance of collapsing a lung.
The other option involves taking out a wedge of lung tissue via an open chest surgical procedure. The only option that has thus far been palatable up to now for a majority of patients is what is known in the healthcare field as "watchful waiting," representing the patients that inReach is seeking to reach.
After a patient is diagnosed, the system can tag a lesion for radiation treatment or inject a dye to make the lesion easier to spot for surgery and the company is currently working with some other partners to add drug delivery and cryotherapy options to the arsenal of treatment options it can provide a patient.
"inReach assists physicians in reaching distant locations in the lungs, helping patients avoid more invasive procedures for diagnosing cancer," said Sullivan. "Many years ago, the angiogram transformed cardiac care because for the first time doctors could diagnose and treat the heart without opening the chest. We believe inReach can have the same dramatic effect on the pulmonology field, providing an option for patients with lesions that previously were unreachable."
Sullivan said the capital component for the inReach, which was cleared for marketing in the U.S. in September 2007, costs about $150,000 and the disposable component sells for about $1,000.
Looking to develop a bioabsorbable coronary stent is REVA Medical (San Diego), whose Chairman Bob Stockman said his company has finally emerged from a 10-year odyssey in its quest to perfect the stent geometry.
Sullivan noted that in the earliest days of stent design, the big companies involved in the space had sought to design absorbable stents but they were handicapped by both the materials available to them at the time as well as the geometries of the stents, which he characterized as "too thick and stubby," which prevented a practical root for stenting an artery open.
More recent efforts to develop bioabsorbable stents have so far met with limited success, he said, mainly because the stent fails to provide adequate support for the vessel over an adequate period of time, as exemplified by the first version of the Absorbable Metal Stent (AMS) from Biotronik (Berlin, Germany).
When researchers at REVA first decided to create a degradable stent, they already had the design in hand. They had recently developed a metal stent with a novel "slide and lock" design, in which the stent unfolds in the artery like an extension ladder instead of bending and expanding outward like most other stents.
The second challenge was finding the right material for the absorbable stent. Researchers at Rutgers University (Camden, New Jersey) helped the company develop a stent that is comprised of a tyrosine-derived polycarbonate material that has strength, flexibility, recoil and X-ray visibility equivalent to that of metal. A paclitaxel-eluting version also is in development.
As opposed to metallic drug-coated stents, Stockman said REVA's product addresses concerns regarding incomplete healing and late-stage thrombosis in patients, as well as reducing the need for long-term anti-platelet medication.
REVA, which commenced first-in-man trials in June 2007 (the RESORB trial), has established a broad strategic relationship with Boston Scientific (Natick, Massachusetts).
Emphysema treatment option
Spiration (Redmond, Washington) is the maker of the IBV Valve, which is under investigation for use as a new treatment for patients with severe emphysema.
President/CEO Richard Shea said the system is designed to redirect airflow from diseased portions of the lung to healthier areas. He said that during a minimally invasive procedure, the catheter is passed through a bronchoscope to deploy the small umbrella-shaped valves into the airways of the most diseased upper lobes of the lungs. Although the valves are intended to be permanent, they are designed to be removed via a minimally invasive procedure if necessary.
Shea said the company already has done a 91-patient pilot study for use of the system in the U.S. as a new treatment option for patients with severe emphysema and is currently enrolling for a randomized, prospective, double-blind, controlled pivotal trial.
The company received a Humanitarian Device Exemption (HDE) for the system last October, specifically for patients who have lobectomy, segmentectomy or lung volume reduction surgery. This HDE, said Shea "represents the first for a bronchial valve implant for the lungs designed specifically to address this complication."
In Europe, the system already has received CE-mark clearance for diseased and damaged lung, a broad indication that includes the treatment of emphysema and the resolution of air leaks.
Spiration granted Olympus (Tokyo) and its distributors exclusive marketing and distribution rights for the IBV Valve System in 43 European countries, including the UK and other countries belonging to the European Union, representing what it said is the broadest distribution arrangement for a bronchoscopic treatment for emphysema in Europe.
Shea called the market in the U.S. alone for this system a more than $1 billion opportunity. "There are clearly a bunch of other indications for the valve," Shea said. "Over time, we would like to be able to help a broader group of patients."
Spiration is backed by an impressive group of investors, including Three Arch Partners, New Enterprise Associates, Versant Ventures, New Leaf Ventures (Sprout Group), InterWest Partners, Investor Growth Capital, Saints Capital and Olympus.
Presenting Flowcardia's (Sunnyvale, California) portfolio of catheter-based technologies to facilitate crossing of totally occluded coronary and peripheral arteries was company President/CEO Wick Goodspeed.
According to Goodspeed, chronic total occlusions (CTOs) are considered one of the last major clinical challenges in interventional therapy. He noted that the absence of a safe and effective CTO recanilization system is a major reason that a large number of patients are still referred to coronary and peripheral bypass surgery and lower limb amputation.
The company received an FDA 510(k) clearance for peripheral arterial disease (PAD) in December 2007 and for coronary arteries in January of that same year. The company's Crosser catheter uses high-frequency mechanical vibration, which acts like a jackhammer to unblock the vessel and allow for subsequent angioplasty or other device follow-up.
Goodspeed said that recently, there have been dramatic improvements in both morbidity and mortality when CTOs are opened. He also noted that there have been "technology improvements that will follow opening of a CTO." On the peripheral side he noted the use of arthrectomy, stents, cryoplasty and laser devices. On the coronary side, drug-eluting stents are still the rage. "Even though these [CTOs] are hard to treat, it's really worth it to open them because the benefit is there and if you can get them open, you can keep them open with drug-eluting stents and through other means."
Goodspeed estimated the worldwide market for CTOs as being around $800 million.
Offering spinal product platforms in both degenerative and scoliosis sectors is Paradigm Spine (New York).
Currently the company markets four products for the treatment of degenerative spine diseases. These include: the coflex Interlaminar/Intespinous stabilization device; the coflex-F posterior stabilization device; the DCI system designed as a functionally dynamic cervical spine implant; and the recently released DSS spinal stabilization system. The DSS system is a pedicle screw-based, implantable dynamic spine stabilization system indicated for degenerative disc disease (DDD) of the lumbar spine. The DSS system incorporates a hybrid philosophy, combining elements of fusion and motion preservation.
Chris Hughes, the company's president of U.S. operations, said Paradigm also is working on a predictive diagnosis opportunity for pediatric scolisosis.
The trials are being conducted at Sainte-Justine University Hospital Center (Montreal). Paradigm entered an agreement with Sainte-Justine to provide cash and "various other resources" through 2008 to complete trials of a blood test developed by Dr. Alain Moreau, director of Sainte-Justine's Bone Molecular Genetics and Skeletal Malformations Laboratory.
Paradigm will receive the exclusive worldwide license to commercialize, make, distribute or sub-license any device, genetic tests, therapeutic agents or "any future technology" developed based on Moreau's research.
The blood test is for determining melatonin-signaling dysfunction in children. And the level of that dysfunction that can be correlated with the scoliotic curve and the evolution of that dysfunction.
In the U.S. the company has launched the DSS Pedicle Screws and Slotted Couplers in August 2008. The company received FDA approval in November for the Rigid Couplers and launched these couplers earlier in January.
Big deal sharpens focus on ophthalmology
The ophthalmology world was taken aback on Jan. 12 by the unexpected news that Abbott Laboratories (Abbott Park, Illinois) was purchasing Advanced Medical Optics (AMO; Santa Ana, California).
Whether this stimulated interest in the other ophthalmic companies presenting at the JP Morgan conference, which opened that same day, is probably sheer conjecture, but it certainly seemed that the proposed acquisition stirred interest in the sector.
The world's largest ophthalmic company, Alcon Laboratories (Fort Worth, Texas), enjoyed a large attendance at its presentation early on the morning of the 12th. Its longtime and venerable CEO, Carey Rayment, who very recently announced his retirement, told his audience that Alcon performed very well in 2008.
Indeed it has, as previously reported sales for the nine months ended Sept. 30 grew over 16% above 2007, while reported net income leaped 34%. Alcon will report its full-year fiscal 2009 results on Feb. 12.
Rayment noted that this stellar performance has been spearheaded by three key factors: market share gains across most its major business segments, new product approval and the introduction of key products into new markets.
Discussing its market share gains, Rayment noted that "we have performed especially well in pharmaceuticals," where Alcon has garnered share in key therapeutic categories such as glaucoma, anti-infectives and anti-histamines.
Glaucoma medications represents the largest global eyecare prescription drug category and Alcon's already strong market position will benefit in 2009 by the recent CE-mark approval of Azarga, a combination drug that Rayment said will offer "powerful efficacy and superior comfort over competing products.
He also expressed confidence in the anti-histamine nasal spray Patanase, which was launched in the U.S. in May 2008, too late to participate in the 2008 allergy season. Rayment believes that Patanase will fare very well in 2009.
Rayment admitted that he was surprised by the decline in the domestic eyecare drug market in the last half of 2008, speculating that it was related to the slumping economy. However, Alcon has registered growth in this category with its impressive market shares gains.
Within its medical device segment, Alcon's performance also has been solid, with noteworthy share advances in intraocular lenses (IOLs), phaco-emulsification (cataract removal equipment) and viscoelestics, used during cataract surgery.
Looking ahead, Rayment cited the recent FDA approval of the ReSTOR 3.0 multifocal IOL, which received a CE mark in 3Q08 and FDA approval late in 4Q08. He presented data showing that the 3.0 version provides improved vision at all distances over the predecessor 4.0 model, but especially in the intermediate zone, where the 4.0 model was mediocre.
"We are very excited with this approval and expect that the ReSTOR 3.0, which has received enthusiastic support from our clinicians, will be a very important new product for us," Rayment said.
Alcon has been facing vigorous competition from the Eyeonics Crystalens, which has been marketed by Bausch & Lomb (Rochester, New York) since its acquisition about one year ago. With a robust performance in 2008, especially in the second half of the year following the debut of the third-generation Eyeonics HD Crystalens, Eyeonics has captured an increased share of the premium IOL market, mostly at Alcon's expense. In fact, with a robust fourth quarter, it appears that Eyeonics took over the No. 1 position in the domestic premium IOL market.
Privately owned, venture capital-backed Visiogen (Irvine, California) made its first appearance at an investment conference last week, presenting information on its premium IOL tradenamed Synchrony. This unique and proprietary IOL addresses the same market as ReSTOR and Crystalens and is poised to become a sturdy competitor.
President and CEO Reza Zadno, PhD, said that the premium IOL market offered "uniquely aligned incentives," providing a "win-win-win" for patients, physicians and manufacturers.
He explained that patients profit by having access to superior vision and an "improved lifestyle," ophthalmologists enjoy "attractive procedure economics" earning about $2000 per IOL implant, compared to about a Medicare reimbursement of $650 for a standard IOL.
IOL manufacturers participate in a large and growing market with a "compelling financial model," because of an average selling price of about ten times the $100 revenue for a standard monofocal IOL. As such, it affords a lucrative gross margin well in excess of 80%.
Zadno, who has earned an excellent reputation for his deft management since founding the company in 2001, characterized Synchrony as an advanced generation premium IOL. Featuring a dual optic, accommodating lens that has been proven with advanced imaging technology to truly accommodate, as well as an easy-to-use, procedure simplifying pre-loaded injector, its clinical performance has been excellent.
For example, Zadno cited a randomized double masked study presented at the European Society of Cataract and Refractive Surgeons (Dublin, Ireland) in Berlin in September 2008 that compared the ReSTOR lens with Synchrony. Whereas 76% of ReSTOR patients achieved 20/40 intermediate vision, 100% of Synchrony patients did. Synchrony also demonstrated a remarkable freedom from halos and glare, which plagued about 25% of ReSTOR patients.
Intermediate vision is particularly important to patients because this is the distance function that they use while using a computer or in any type of "Blackberry activity."
Visiogen already has achieved CE-mark approval and will begin to commercialize in Europe this month. In the U.S., the company has completed enrollment of its pivotal PMA trial and the mandated one-year follow-up. It will shortly file its PMA and hopes to launch in mid-2010.
He concluded his talk by saying that his management team has delivered on budget and on time and expects to make a significant impact on the premium IOL market.
Another presenting ophthalmic company was Cooper Companies (Pleasanton, California), which consists primarily of its CooperVision global contact lens (CL) company (84% of revenue) and the smaller (16% of revenue) CooperSurgical women's health division.
The company's CEO, Bob Weiss, said that Cooper is the third-largest player in the $5.5 billion to $6 billion global CL market, with an approximate 16% share. It trails Johnson & Johnson (New Brunswick, New Jersey), which has a 44% share and Ciba Vision (Duluth, Georgia), with a 22% share. It leads Bausch & Lomb, which has a 14% share.
Weiss discussed recent trends in the CL industry, indicating that the slumping economy appears to be having an impact on demand. He noted that Cooper's contact lens revenue in October, the last month of its fiscal year, was "dismal," while November also was "bad." Volume in December appears to have stabilized and grown modestly. He quipped that "perhaps we are not recession-proof as we thought, but maybe we are recession-resistant."