STAAR Surgical receives CE Mark. STAAR Surgical (Monrovia, CA) received the "CE Mark" for the SonicWAVE Phacoemulsification System used for cataract removal. The approval gives the company access to the $300 million European Union market for cataract-removal devices and accessories. The company expects to ship its first systems in June 2001.
Package to link Sunrise and B&L. Sunrise Technologies International (Fremont, CA) and Bausch & Lomb (B&L) are discussing the option of bundling the Sunrise Hyperion LTK System with the Bausch & Lomb excimer laser to entice refractive surgeons to buy products from one vendor. The refractive surgeons who agreed to the purchase package would have both an excimer laser for treatment of myopia and the Hyperion system for hyperopia treatment at a better price than they could purchase the systems separately.
Icahn and VISX follies continue. In the latest of the Icahn/VISX confrontations, the two accused each other of vague, even vapid remarks. Icahn, who offered $1.9 billion ($32 per share) to acquire the company and was rejected, observed, "I cannot understand why VISX does not simply accept my proposal to submit to shareholders the best offer of $32 per share or higher if they are serious about pursuing an acquisition." VISX on the other hand, stated that it is skeptical about Icahn's willingness to provide the necessary funding and has retained Goldman Sachs to help it investigate all alternatives. Just before going to press, MLR learned that VISX will permit Icahn's bid of $32 per share but said that he was "disingenuous" in his bid at that price. And so, the comedy is not yet finished.
LCA-Vision procedure volume rises. LCA-Vision (Cincinnati, OH) reported that procedures performed at its LasikPlus centers reached 25,061 at the end of March 31, 2001, compared with 12,504 procedures performed at the quarter one year ago. LCA-Vision's CEO Tom Wilson attributes the company's success to its varied types of laser technology, allowing the consumer a vast choice of laser procedure and laser type. Pricing also figured into the laser vision-correction service company sales. Wilson notes, "Due to our tiered pricing, we are able to increase market realization while both matching our competitors' lowest prices and increasing market share."
Spectranetics procedure effective. Spectranetics' (Colorado Springs, CO) German investigators have found that excimer-laser angioplasty is successful in treatment of long lesions in the superficial femoral artery (SFA). Study results were published in the April Journal of Endovascular Therapy of 318 consecutive patients who received the laser treatment. According to Dr. Giancarlo Biamino of the Center for Cardiology in Hamburg, Germany, a study participant, "Excimer-laser angioplasty has been approved in Europe since 1996 for the treatment of arteries in the thigh, and I have personally performed thousands of such procedures with tremendous success. Results from this study are typical of my experience, with more than 90% of cases with excellent clinical results." The company plans to complete enrollment in a US study for its excimer-laser treatment of the upper leg before then end of 2001. The company is conducting another study of excimer-laser treatment of the SFA that is intended to improve circulation in the lower leg, which should have completed patient enrollment in early 2002.
Paradigm Medical receives CPT code. Paradigm Medical Industries (Salt Lake City, UT) received authorization to use a common procedure terminology code (CPT) from the CPT Code Research and Development Division of the American Medical Association for its Ocular Blood Flow Analyzer (BFA). The BFA collects data about the blood flow to the eye, which may permit early identification of patients with glaucoma, increasing physicians ability to curb irreversible retina damage. The CPT codes are valuable for all procedures because they streamline physician reimbursement, thereby encouraging physician use. Reimbursement for the procedure is $57 per patient.
SurgiLight submits 510(k) for EX-308. SurgiLight (Orlando, FL) recently submitted its second 510(k) premarket notification for its EX-308 excimer laser, this time for phototherapeutic treatment of vitiligo. The EX-308 laser received clearance for treatment of psoriasis in August 2000, and the company expects to begin shipping the system internationally using the marketing capabilities of A & A Medical, a medical-device manufacturer. SurgiLight will also begin placing the EX-308 at its Advanced Medical Laser Services (AMLSI), its wholly owned mobile cosmetic center servicing the southeast.
Candela Laser approved. Candela Corp. (Wayland, MA) received FDA approval for its GentleYAG laser, which is useful for hair removal in darker-skinned patients, including skin type V and VI. The device has a longer wavelength (1064 nm) that is deeply penetrating and, with this pulse, is capable of deep penetration. According to Kathleen McMillan, vice president of research, "the 1064-nm wavelength is so deeply penetrating, the deeper follicular targets absorb the GentleYAG pulse and are heated, resulting in eradication of the hair."
Photogen therapy is successful. Photogen Technologies (New Hope, PA) completed a successful pilot clinical study using PH-10, its photosensitizer activated by green light, to treat plaque psoriasis. Several patients had treatments of PH-10 and laser on one psoriasis area, laser alone on another, and no treatment elsewhere. The combination therapy showed the best results. Says Peter Bjerring, principal investigator, "These interim results, while at an early point, are quite encouraging. PH-10 therapy should be studied as a new treatment for this chronic disease." As a result of these positive findings, Photogen has begun a Phase 1 human clinical study examining the effect of three different dosages of PH-10, its topical treatment for psoriasis. Patients in the study will each be treated as they were in the pilot study with a single dose of PH-10 and green light on one area and nothing on the other.
Abbott Labs finances SpectRx Monitor. Abbott Laboratories will assume financial responsibility for the SpectRx (Norcross, GA) glucose monitor. Under a 1999 agreement, Abbott gained exclusive worldwide marketing rights to the SpectRx interstitial fluid glucose-monitoring device by agreeing to finance and offer milestone payments for product development. SpectRx expects to receive $2 million in a milestone payment from Abbott to continue its research, clinical testing, and engineering activities. The product under development will measure interstitial fluid (ISF) rather than blood. ISF is collected through an array of microscopic holes created with a laser and measured in a patch containing a glucose sensor. The sensor patch should be viable for up to three days.
Financial Scoreboard
LaserSight (Winter Park, FL) Q4 revenues for the period ending December 31, 2000, were $6.4 million, up 64% from the $4.6 million in the fourth quarter of 1999. The company reported a net loss of $12.0 million, compared with a net loss of $4.6 million in the fourth quarter of 1999. The company ended the year with revenues of $34.5 million, an increase of approximately 59% from $21.7 million in 1999. Net loss for 2000 was $21.7 million, compared with a loss of $19.9 million in 1999.
VISX (Santa Clara, CA) released a comment on Icahn's Revised Preliminary Proxy Filing to stockholders together with a record of its Q4 earnings. The company's first quarter 2001 revenue was $51.6 million, compared to $64 million for the comparable period in 2000. The company's net income was $12.6 million, compared to net income of $19.6 million in Q4 2000. The company statement to stockholders advised that it found nothing new in Icahn's revised platform to auction the company and that the VISX board of directors and management remain receptive to any opportunity that recognizes VISX's profitable performance and global leadership.
Eclipse Surgical Technologies (Palo Alto, CA) Q1 revenues were $3.1 million with a net loss of $2.4 million, compared to revenues of $5.7 million and net loss of $4.4 million in 2000. The loss was incurred because Q1 2000 sales were mostly from lasers, while Q1 2001 sales were primarily from disposables.
Spectranetics Corp. (Colorado Springs, CO) announced revenues of $6.1 million for the first quarter of 2001, compared with revenues of $6.7 million for the same period one year ago. The company attributes revenue loss to implementation of a strategic plan emphasizing US disposable products sales and de-emphasizing international sales. The company incurred a net loss of $556,000 in Q1 2001, compared with a net loss of $894,000 in 2000.
Laserscope (San Jose, CA) posted first-quarter revenues of $8.2 million in 2001 as compared with revenues of $8.6 million in the first quarter one year ago. Net loss in 2001 was $490,000, compared with a net loss of $352,000 in the first quarter of 2000.
American Medical Technologies (Corpus Christi, TX) reported decreased revenues in Q1 2001 but first-quarter profit in 2001 vs. first-quarter loss in 2000. Revenues for the first quarter 2001 were $4.5 million, down 4% from last year's revenues of $4.7 million. However, the company recorded a net income of $104,833 in 2001, compared with a net loss of $745,980 in 2000.
Candela (Wayland, MA) Q3 revenues were $18.8 million, compared to revenues of $19.2 million for the same quarter last year. Net income for this period was $1.6, compared with net income of $3.7 for Q1 of 2000.
Palomar Medical (Burlington, MA) ended the first quarter of 2001 with revenues of $3.6 million, compared with revenues of $2.9 million in Q1 of 2000. Net loss for the first quarter 2001 was $1.9 million, compared with a net loss of $3.6 million in the previous year. Gross profit in Q1 2001 was $887,000 or 25% of revenues, compared to a gross profit of $303,000 or 11% of revenues in Q1 2000.
Coherent (Palo Alto, CA) Q2 bookings and sales for Q2 2001 were $179.8 million and $183.8 million, respectively, representing increases of 9% and 29% of the $126.8 million and $129.8 million continued and discontinued operations of the same period in 2000. Net income for Q2 2001 was $14.7 million, an increase of 75% over last year's $11.3 million Q1 revenues. Addressing Coherent's sale of its medical-laser division to ESC Medical Systems Ltd., Bernard Couillaud, Coherent's president and CEO, said that he expected "the new company Lumenis would be a world leader in laser-based medical systems."
Source: Medical Laser Report, May 2001
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