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50 Companies to Watch


Posted in Medical Device Business by Heather Thompson on June 2, 2010

MD+DI shines a light on notable companies.


Choosing just 50 companies to watch in the medical device industry is no easy task. After all, the industry is known for its diversity, not to mention its daily innovations. The challenge for MD+DI editors was to identify not only those companies that have achieved success, but also to find those manufacturers with the potential to revolutionize care practices. To that end we found some companies you may not have heard of, and we found some that may not even have products on the market.

We solicited nominations from readers, our Editorial Advisory Board and Reader Board, and industry observers. We meticulously analyzed any information we could get our hands on about each nominee, and then we debated among ourselves until we produced the list you see on the following pages.

There are some firms whose products walk the line of what constitutes a medical device. Biologicals and other convergent trends are blurring traditional categorizing, and MD+DI editors felt that the evolving medical device space allowed for some firms to erase that line altogether.

Another trend that emerged was the number of orthopedic companies that were selected. These firms often boast both groundbreaking technology and something altogether more rare these days—profit. Several of these companies have seen growth over the last year, a trend not everyone could report during a recession.

This isn’t a ranking, nor is it a declaration of the top, best, or most-likely-to-succeed companies in the device industry. The firms are listed alphabetically, for the most part, so what’s important is the content, not the order. And what you’ll find are tales of companies that are making an outstanding contribution to healthcare and that are expected to continue doing so.

There are certainly many companies we’ve forgotten, overlooked, or otherwise cast aside. With humility, here are the editors’ 2010 selections for ­­50 Companies to Watch.

 

Ben Pless, president and CEO

Autonomic Technologies (ATI)
Redwood City, CA
Annual revenue: N/A (privately held)
Key products: Migraine headaches treatment
Reason to watch: Its novel treatment for migraine headaches may revolutionize treatment methods. The design team is led by management with success in medical implants as well as investment teams that are convinced that even in the down economy, ATI’s product will be the next big thing in the neurotechnology industry. This is a company with a vision. The Cleveland Clinic-backed company raised $20 million in Series B funding in May 2010.
www.autonomictechnologies.com

Greg Baldwin, CEO and chairman of the board

Baxa Corp.
Englewood, CO
Annual revenue: $146 million (FY ended 12/09)
Key products: DoseEdge system
Reason to watch: The company promotes pharmacy safety. Its STAR Center (skills training, academics, and resources) was created for professional development in pharmacy, healthcare, and environmental control. Baxa believes that the best way for pharmacists to understand and implement state-of-the-art standards of practice is for them to have a practical, hands-on experience with expert faculty. It is committed to promoting safety in pharmacies.
www.baxa.com

 

Edward L. Erickson, president and CEO

BioNanomatrix Inc.
Philadelphia
Annual revenue: N/A (privately held)
Key products: NanoAnalyzer and Nanochannel Array
Reason to watch: The developer of whole genome imaging and analysis platforms for biomedical research, molecular diagnostics, and personalized medicine has a low-cost nanofluidic genome analysis technology. It is applying expertise in nanosystems to provide analysis of genomic and epigenomic data with sensitivity at the single-molecule level. It has a federally funded project to sequence the human genome in eight hours at a cost of $100.
www.bionanomatrix.com

 

Paul J. Southworth, president and CEO

CircuLite Inc.
Saddle Brook, NJ
Annual revenue: N/A (privately held)
Key products: Synergy partial circulatory-assist device
Reason to watch: Due to the lack of heart-transplant donors, circulatory support is becoming necessary for many patients suffering from congestive heart failure. CircuLite has developed a miniature circulatory-assist device (about the size of an AA battery) that is implanted using minimally invasive techniques that potentially could help ~2 million patients worldwide who have failed pharmacological and rhythm management therapies.
www.circulite.net

 

Charles R. Klasson, president

CIVCO Medical Solutions
Kalona, IA
Annual revenue: N/A (part of Roper Industries)
Key products: Protura 6 Degree of Freedom
Reason to watch: The company has developed a technical breakthrough in precision and is introducing  the Protura 6 Degree of Freedom robotic couch for radiation therapy. The Protura will work with most linear accelerators. When combined with the company’s Universal Couchtop and SBRT Body Pro-Lok, it becomes an all-in-one motion management system.
www.civco.com
 

 

Philipp Lang, MD, CEO, president, chair

ConforMIS Corp.
Burlington, MA
Annual revenue: N/A (privately held)
Key products: Patient-specific knee implants
Reason to watch: The company has shown rapid growth and phenomenal market acceptance and recognition for its patient-specific knee implants. These patient-specific implants have been shown to be a superior alternative to off-the-shelf knee implants. In April 2010, the firm received a CE mark for its iUniG2 knee resurfacing implant.
www.conformis.com

Mel Schatz, president and CEO

Crux Biomedical Inc.
Menlo Park, CA
Annual revenue: N/A (privately held)
Key products: IVC filter system
Reason to watch: The Crux Biomedical IVC filter is the world’s first bidirectionally retrievable filter system. Its helical geometry makes it capable of dynamically adapting to vena cava diameters and shapes. The coaxial over-the-wire delivery system is the first of its kind for IVC filter delivery. It provides ease of use, precision deployment, and user-controlled release of the implant. The firm just received FDA approval in the United States.
www.cruxbiomedical.com

Patrick R. Spearman, CEO 

Envoy Medical Corp.
St. Paul, MN
Annual revenue: N/A (privately held)
Key products: Esteem surgical implanted prosthetic hearing restoration device
Reason to watch: FDA recently approved Envoy to market a “first of its kind” prosthetic hearing restoration device. The approval follows a unanimous vote by a 15-member independent advisory panel in favor of approving the Esteem for moderate to severe sensorineural hearing loss. FDA expedited the review process, noting that it believes the Esteem “represents a breakthrough technology.”
www.envoymedical.com

Robert J. Palmisano, president and CEO

ev3 Inc.
Plymouth, MN
Annual revenue: $449.1 million (FY ended 12/09)
Key products: Plaque excision systems, embolic protection devices, liquid embolics, retrieval devices
Reason to watch: ev3 is expanding its portfolio of neuro and peripheral products. In 2009, it acquired Chestnut Medical Technologies, a maker of minimally invasive therapies for interventional neuroradiology. In Q1 2010, ev3’s neurovascular segment grew 44% compared with Q1 2009. The company has initiated a trial to evaluate a 200-mm-length stent for treating peripheral arterial disease in the legs.
www.ev3.net

Frederick Moll, president and CEO

Hansen Medical Inc.
Mountain View, CA
Annual revenue: $22.2 million (FY ended 12/09)
Key products: Sensei robotic catheter and Artisan control catheter
Reason to watch: Hansen makes robotic catheter systems that allow surgeons to remotely guide a heart catheter with hand movements while seeing a 3-D view of the operation. Studies show that the systems lead to faster operations than manual catheter techniques. In May 2010, the company received conditional approval for a clinical trial of the Sensei and Artisan to treat atrial fibrillation.
www.hansenmedical.com

Ken Ferry,
president and CEO

iCAD Inc.
Nashua, NH
Annual revenue: $28.1 million (FY ended 12/09)
Key products: Image analysis technology for mammography, CT, and MRI
Reason to watch: iCAD is the only company with an FDA-approved CAD product for computed radiography mammography. Its SecondLook systems can detect up to 72% of missed breast cancers an average of 15 months earlier than screening mammography alone. The company was granted a patent for future iterations of SecondLook for use with the manufacturer’s other image analysis products.
www.icadmed.com
 

Marcelo Lima, president and CEO

ImThera Medical
San Diego
Annual revenue: N/A (privately held)
Key products: Targeted hypoglossal neurostimulation (THN) system
Reason to watch: ImThera is banking on neurostimulation as an alternative to sleep masks used to treat obstructive sleep apnea, which are plagued by patient noncompliance. THN stimulates the nerve that provides motor innervations to tongue muscles. This prevents the tongue from falling into the throat and keeps patients’ airways open. ImThera is currently conducting a pilot study in Belgium.
www.imtheramedical.com

James E. Muller, founder and CEO

InfraReDx
Burlington, MA
Annual revenue: N/A (privately held)
Key products: Coronary imaging system
Reason to watch: InfraReDx’s LipiScan is the only FDA-cleared product that detects and analyzes the intracoronary composition of lipid core plaque. This plaque, believed to cause heart attacks and complicate stenting, typically escapes detection from common diagnostic tests such as treadmill exams and coronary angiograms. The system measures light delivered through the blood and reflected from the artery wall, and eventually creates a map of the artery’s chemical composition.
www.infraredx.com
 

 

J. Joseph Kim, president and CEO

Inovio Biomedical
Blue Bell, PA
Annual revenue: $9.1 million (FY ended 12/09)
Key products: In vivo electroporation device
Reason to watch: By merging with VGX Pharmaceuticals in 2009, Inovio increased its capabilities to develop DNA vaccines. The companies are creating a vaccine that targets H5N1 and have earned approval to test the vaccine in Korea. Inovio was named Best Early-Stage Biotech Company at the World Vaccine Congress in 2010. The award recognized the firm’s electroporation device and development of DNA vaccines for influenza, HIV, and cancer.
www.inovio.com
 

Mike Nash, cofounder, president, and CEO

iScience Interventional
Menlo Park, CA
Annual revenue: N/A (privately held) 
Key product: Microcatheters and microcannulae
Reason to watch: iScience was the first company to develop microcatheter and imaging systems that enable opthalmologists to conduct site-specific surgery.  Its products are used in canaloplasty—a minimally invasive procedure to lower the intraocular pressure in glaucoma patients. Each year about 3000 canaloplasty procedures are performed in the United States and about 2500 are performed outside the United States.
www.iscienceinterventional.com

Emma A. Durand, CEO and CTO

Isis Biopolymer Inc.
Providence, RI
Annual revenue: N/A (privately held)
Key product: IsisIQ active drug-delivery patch
Reason to watch: The company’s early-stage drug patch could give doctors better control of drug delivery. The wireless, active iontophoretic patch is fully programmable, enabling the patch to be customized to the needs of the patient. The improved control also reduces the chance of under- and overdosing. Additionally, the patch is a biosenser that can detect skin emanation, which can be a sign of heart attack, shock, or diabetic reactions.
www.isisbiopolymer.com
 

Eric Major, president and CEO

K2M Inc.
Leesburg, VA
Annual revenue: N/A (privately held)
Key products: Spinal stabilization and minimally invasive systems
Reason to watch: On top of earning multiple 510(k) clearances and industry awards since 2009, the spinal device company is busy expanding into international markets. K2M recently entered a distribution agreement to market products in Germany, opened a sales and distribution office in the UK, and got clearance to market its Mesa spinal system in Japan. Its Serengeti minimally invasive retractor system garnered a Medical Design Excellence Award in 2010.
www.k2m.com

Clyde Pratt, CEO

Kinamed Inc.
Camarillo, CA
Annual revenue: N/A (privately held)
Key products: Implantables and instruments for orthopedics and neurosurgery
Reason to watch: Despite a tough economy, the company has experienced double-digit growth for three consecutive years. Kinamed’s financial success is due to its aggressive international marketing—about 50% of its sales are made abroad—and its ability to meet regulations in countries like Japan and China. Several products are FDA approved and the Gem total knee system is approved for investigational use.
www.kinamed.com

 

Manny Villafaña, founder, CEO, and chairman

Kips Bay Medical Inc.
Minneapolis
Annual revenue: N/A (privately held)
Key products: eSVS mesh
Reason to watch: In 2010, the company filed to raise $57.5 million through an initial public offering. Its CEO, Manny Villafaña, is an experienced entrepreneur who has founded and taken such medical device companies public as St. Jude Medical. Kips Bay’s eSVS mesh is an extravascular prosthesis that is placed over a patient’s saphenous vein graft during coronary artery bypass grafting. The technology is being tested in a multinational clinical trial.
www.kipsbaymedical.com

Maurice R. Ferré, president, CEO, and chairman

Mako Surgical Corp.
Fort Lauderdale, FL
Annual revenue: $34.2 million (FY ended 12/09)
Key products: Rio Robotic Arm Interactive Orthopedic System
Reason to watch: In just five years, the company developed Makoplasty, a procedure to perform joint resurfacing on the knee that preserves tissue, and received FDA clearance for a robotic arm system used in the surgery. In Q4 2010, 561 procedures were performed—a 181% increase from Q4 2008. The firm is currently investigating whether Makoplasty has applications to the hip, shoulder, and spine.
www.makosurgical.com
 

Gopal Muppirala, CEO

Mardil Inc.
Morrisville, NC
Annual revenue: N/A (privately held)
Key products: Mitral valve repair device
Reason to watch: Mardil’s external BACE (Basal Annuloplasty of the Cardia Externally) device addresses functional mitral valve regurgitation with technology that supports the heart muscle rather than the valve itself. Postoperative remote adjustments can be made by a cardiologist through subcutaneous ports. Both the initial prototype and pilot study showed significant improvement in the degree of mitral regurgitation, ejection fraction, functional status, and quality of life.
www.mardil.com

Joe Kiani, CEO


Masimo Corp.

Irvine, CA
Annual revenue: $349.1 million (FY ended 1/10)
Key products: Noninvasive patient monitors
Reason to watch: Masimo’s Rainbow SET Pulse CO-Oximetry platform is the first and only FDA-cleared technology that noninvasively and continuously measures total hemoglobin. The company expects it to open new markets and expand growth. The OEM established the Masimo Foundation for Ethics, Innovation, and Competition in Healthcare. It supports programs for patient safety and expanding access to healthcare.
www.masimo.com

 

Frank Codella, CEO

Medical Acoustics LLC
Buffalo, NY
Annual revenue: N/A (privately held)
Key Products: Lung Flute
Reason to watch: The Lung Flute is a disposable device that uses a low-frequency acoustic wave to collect mucus samples for diagnostic purposes. It’s a noninvasive alternative to hypertonic saline, which can cause bronchial inflammation. It has the potential to help diagnose or treat lung cancer, tuberculosis, chronic bronchitis, asthma, and community-acquired pneumonia. Popular Science magazine named the device a best innovation for 2009.
www.medicalacoustics.com

Ajit S. Gill, president and CEO

 

MicroCHIPS
Bedford, MA
Annual revenue: N/A (privately held)
Key products: Glucose monitor, drug-delivery devices
Reason to watch: MicroCHIPS builds devices based on reservoir arrays that store and protect chemical sensors or drugs in the body for long periods of time. The arrays are compatible with microprocessors, wireless telemetry, and sensor feedback loops. In 2010, the World Economic Forum named the company a technology pioneer. It also received a 2010 Edison Best New Product Award for its Illume product. Its IP portfolio includes 25 patents and 40 pending applications.
www.mchips.com

 

Wayne Poll, MD, CEO

Minimally Invasive Devices (MID)
Columbus, OH
Annual revenue: $750,000 (FY ended 12/09)
Key products: FloShield
Reason to watch: MID’s core technology improves surgeon visualization. During laparoscopic procedures, condensation can form on the end of the laparoscope, which can obscure vision. Instead of removing the scope during surgery to clean, the FloShield flows carbon dioxide over the lens to keep away debris. The OEM is looking at device concepts from universities as potential technologies for development and commercialization.
www.midsurgical.com

Michael Afremov, president and CEO

Minnesota Medical Development Inc. (MMDI)
Plymouth, MN
Annual revenue: N/A (privately held)
Key products: Rebound HRD
Reason to watch: MMDI developed the only hernia repair device that uses a nitinol frame and mesh. Rebound HRD withstands laparoscopic deployment and reduces procedure time by 50%. The device received the Innovation of the Year Award from the Society of Laparoendoscopic Surgeons in 2006, before it had received 510(k) clearance. MMDI says the device is gaining market share.
www.2mdinc.com

Chris Rowland, CEO

Neotract Inc.
Pleasanton, CA
Annual revenue: N/A (privately held)
Key products: UroLift System
Reason to watch: Start-up Neotract is preparing to launch UroLift for treating benign prostatic hyperplasia. The UroLift System directly opens the urethra without removing or ablating prostate tissue. It is an alternative to invasive transurethral resection of the prostate. Sutures are placed transurethrally to retract the obstructing prostatic lobes while leaving the prostate intact. Clinical results have shown symptom relief within two weeks and preserve long-term normal sexual function.
www.neotract.com

Alexel Marko, CEO and director

Neovasc Inc.
Richmond, BC, Canada
Annual revenue: $3 million Canadian (FY ended 12/09)
Key products: Neovasc Reducer
Reason to watch: The company’s product treats refractory angina. It has raised funding for a multicenter clinical trial intended to demonstrate the safety and efficacy of the Reducer product for this indication in patients lacking other treatment options. The company says results will provide key data for a CE mark application and will help drive adoption. The company expects its biological tissue business to be profitable in 2010.
www.neovasc.com

 

Frank Fischer, CEO

Neuropace Inc.
Mountainview, CA
Annual revenue: N/A (privately held)
Key products: Neurostimulator for epilepsy
Reason to watch:  Neuropace’s neurostimulator provides hope for patients who have unsuccessfully tried drug treatment to reduce seizures. The cranial implant is attached to surface or deep brain electrodes that can detect the early electroencephalograph signal that precedes a seizure. The device stimulates the brain to stop or prevent the spread of the seizure. The company filed its PMA for the device following a successful pivotal clinical trial.
www.neuropace.com

 

Laura King, president and CEO

NeuWave Medical Inc.
Madison, WI
Annual revenue: N/A (privately held)
Key products: Microwave ablation
Reason to watch: NeuWave Medical’s Certus 140 is a soft tissue ablation system with pending FDA clearance. It was designed to minimize invasiveness and provide an ergonomic user interface. NeuWave is the result of an academic collaboration between engineers and physicians who wished to improve clinical outcomes. Raising venture capital enabled NeuWave to attract a strong leadership team, driving product conception to submission within 24 months.
www.neuwavemedical.com

Jeffrey Morrill, CEO

NuOrtho Surgical Inc.
Falls River, MA
Annual revenue: N/A (privately held)
Key products: Tissue preservation RF probe
Reason to watch: NuOrtho Surgical focuses on treating damaged tissue and preserving healthy tissue. Its radio-frequency device can use a standard monopolar generator located in any operating room. NuOrtho has three main product platforms—soft tissue treatment, agent delivery, and bone fusion. Its first product launch will be Ceruleau, a technology for knee cartilage. The company’s nine patents could pave the way for opportunities in tissue preservation.
www.nuorthosurgical.com

Alexis V. Lukianov, president and CEO

NuVasive
San Diego
Annual revenue: $370.3 million (FY ended 12/09)
Key products: Spine surgery procedures, implants, and instruments
Reason to watch: Among private companies that go public, NuVasive is a poster child of how it’s done. NuVasive’s total revenue is up 48% from 2008, and it expects annual sales of $500 million this year. Its spinal device is based on spreading the psoas muscle rather than cutting it. A software algorithm allows the surgeon to see where the nerves are in real time. Despite hiccups in getting reimbursement, the firm has built a strong base of loyal patients.
www.nuvasive.com

Jeffrey Burbank, president and CEO

NxStage Medical Inc.
Lawrence, MA
Annual revenue: $148.7 million (FY ended 12/09)
Key products: NxStage System One, NxStage PureFlow SL
Reason to watch: NxStage has expanded with international partnerships. In 2007, it acquired Medisystems, a dialysis firm that provides technology for the System One, the first FDA-cleared hemodialysis tool used in the home. MassMEDIC gave the company a Medical Device Innovation Award in the start-up category in 2005. In 2009, its revenues grew 31% for its home dialysis business unit. The firm finished an IPO in 2005.
www.nxstage.com

John Spitznagel, chairman and CEO

Oceana Therapeutics Inc.
Edison NJ
Annual revenue: N/A (privately held)
Key products: Deflux, Solesta, Uriprine
Reason to watch: Within a year of start-up in 2008, Oceana acquired rights to two medical products. Deflux, a gel used in endoscopic injections to treat pediatric urinary conditions, recently received approval in Japan. In 2009, Oceana obtained exclusive marketing rights to Solesta and in April 2010, it filed for PMA. Oceana is developing Uriprene, a biodegradable ureteral stent, which eliminates a second procedure for device removal.
www.oceanathera.com

 

John Stalcup, CEO

Osseon Therapeutics
Santa Rosa, CA
Annual revenue: N/A (privately held)
Key products: Osseoflex, Osseoperm
Reason to watch: Since launching in early 2009, Osseon’s technology has been used on more than 700 patients. It focuses on bone cement delivery devices and bone cement composite for treating symptomatic compression fractures of the vertebral spine. Osseon is a spinoff of the University of Northern California. The university, founders, and private investors have raised $14 million for the start-up, including $6 million in a recent round.
www.osseon.com

 

Jeffery W. Millin, president and CEO

Pioneer Surgical Technology
Marquette, MI
Annual revenue: N/A (privately held)
Key products: Quantum Spinal Rodding System; nanOss Bioactive
Reason to watch: Pioneer has made a push into orthobiologics and expanded its spinal implants offerings. In 2006, the firm formed a distribution agreement with Regeneration Technologies, which makes BioSet demineralized bone matrix. Also in 2006, Pioneer acquired Encelle Inc. (renamed Pioneer Surgical Orthobiologics), which makes E-Matrix, a sterile, injectable biopolymer for the repair of diseased or damaged tissue.
www.pioneersurgical.com

Keiran T. Gallahue, president and CEO

ResMed
San Diego
Annual revenue: $921 million (FY ended 12/09)
Key products: Activa LT and swift LT for Her sleep-disordered breathing devices
Reason to watch: ResMed has seen revenue growth and sustained sales and has gained market share with sleep-disordered breathing devices. Sleep apnea, snoring, and other respiratory disorders are linked to complications and increased risk in diabetes and heart failure. ResMed has made research and education its priority. Strategic acquisitions, partnerships, and international markets enhance the firm’s growth potential.
www.resmed.com

S. Wayne Kay, CEO

Response Biomedical Corp.
Vancouver, BC, Canada
Annual revenue: $9.95 million Canadian (FY ended 12/09)
Key products: RAMP, a platform lateral-flow immunoassay
Reason to watch: The company’s RAMP system is used in various diagnostic practices. It assists in diagnosis of a heart attack. It is also used in Flu A+B Test, launched in October 2008. The company has made inroads with its Chinese distributor O&D Biotech Co. Ltd. in selling the cardiac products. In February 2010, the company added a second such distribution partner in China, Wondfo Biotech Co. Ltd.
www.responsebio.com

David L. Lucchino CEO and cofounder

Semprus BioSciences
Cambridge, MA
Annual revenue: N/A (privately held)
Key products: Semprus Surfaces platform to address adverse reactions to implanted materials
Reason to watch: Founded out of the MIT’s Langer Lab, the company has developed a biofunctional surface platform. Permanent nonleaching biomaterial modification introduced to a device surface is designed to prevent medical complications. In December 2008, Semprus BioSciences completed an $8 million Series A financing. This funding came on the heels of $2.5 million seed capital raised in 2007.
www.semprusbio.com

Jean-Marc Wismer, CEO

Sensimed AG
Lausanne, Switzerland
Annual revenue: N/A (privately held)
Key products: Triggerfish intraocular monitoring system
Reason to watch: Sensimed’s Triggerfish system is a breakthrough in the optics field. It is a soft contact lens embedded with MEMS technology to monitor intraocular pressure for 24 hours a day in patients suffering from glaucoma. Already armed with a CE mark and seeking FDA approval, the product is the first of its kind on the market. It is designed to allow patients to sleep at home instead of in a sleep laboratory.
www.sensimed.ch

 

Charles Scarantino, founder and chair

Sicel Technologies
Morrisville, NC
Annual revenue: N/A (privately held)
Key products: Surface dosimetry radiation measurement devices
Reason to watch: Radiation treatment for cancer is clearly no walk in the park, and accuracy is critical to prevent cancer reoccurrence or damage to healthy tissue. Sicel has developed a tiny sensor (2 mm in diameter) that measures the amount of radiation delivered to a tumor site. Readings are transmitted wirelessly to a reader outside the body. These readings enable doctors to adjust radiation levels to ensure the proper dose.
www.siceltech.com
 


Daniel Sullivan, CEO

SuperDimension
Minneapolis
Annual revenue: N/A (privately held)
Key products: i·Logic system
Reason to watch: SuperDimension has brought the first virtual visualization technique to interventional procedures (bronchoscopy), creating new possibilities in accessing problem areas inside the body. Its offers minimally invasive access to lesions deep inside the lungs as well as mediastinal lymph nodes. The company spearheads a new field called electromagnetic navigation bronchoscopy. Software lets physicians see reconstructions of the bronchial airways of the lungs.
www.superdimension.com
 

Kimble Jenkins, CEO

SurgiVision Inc.
Memphis
Annual revenue: N/A (Privately held)
Key products: MRI-guided intervention technology
Reason to watch: SurgiVision’s ClearPoint neurointervention system is changing the landscape of brain surgery. By integrating medical devices that are compatible with magnetic resonance imaging (MRI), the company is enabling surgeons to perform precise surgery using MRI for guidance. The company is also developing the ClearTrace system for MRI-guided cardiac ablation to treat atrial fibrillation.
www.surgivision.com
 

Rodger G. Ford, CEO 

SynCardia Systems Inc.
Tucson, AZ
Annual revenue: N/A (privately held)
Key products: Total Artificial Heart
Reason to watch: The SynCardia Total Artificial Heart is the only device of its kind with regulatory approval in the United States, Canada, and Europe. The device, meant for people dying from end-stage biventricular failure, works similar to a heart transplant in that it replaces both the right and left heart ventricles. Plus, there’s no waiting list like there is for donor hearts (the company has certified centers set up throughout the world).
www.syncardia.com
 

Ken Moore, CEO 

Tenet Medical Engineering
Calgary, AB, Canada
Annual revenue: N/A (privately held)
Key products: Surgical positioning devices
Reason to watch: Tenet continues improve on advanced patient positioning for surgical procedures. The company has been one of the fastest-growing firms in Canada in recent years, thanks in part to its Spider Limb Positioner. Tenet also has unique ties to the University of Calgary, and not just for recruitment. To continue the innovation cycle, a portion of Tenet’s profits go back to the school to fund more bone and joint research.
www.tenetmedical.com
 

 

Todd M. Pope, CEO

TransEnterix
Durham, NC
Annual revenue: N/A (privately held)
Key products: Laparoscopic instruments
Reason to watch: TransEnterix is a pioneer in flexible laparoscopy. The firm’s SPIDER Surgical System allows  surgeons to perform various procedures through a single incision in the navel. The system opens up like an umbrella, providing the surgeon with two flexible channels for right- and left-hand instruments with 360° range of motion, and two rigid channels for small cameras and other instruments. SPIDER presents a significant shift and may change minimally invasive surgery.
www.transenterix.com

 

Alan Shortall, CEO

Unilife Corp.
Lewisberry, PA
Annual revenue: $4.6 million Australian (FY ended 6/09)
Key products: Safety syringes
Reason to watch: Unilife can significantly improve injection safety with its core safety syringe technology. The needle automatically retracts, and an automatic disable feature prevents reuse. The integration of automatic and controlled needle retraction features could give Unilife a major competitive advantage. The company is capitalizing on increased syringe use, which is partially driven by an aging population, increased incidence of diabetes, and the development of new vaccines.
www.unilife.com

Robert Goldman, founder

Vascular Designs
San Jose
Annual revenue: N/A (privately held)
Key products: Platform lateral-flow immunoassay technology
Reason to watch: Vascular Designs recently launched a potential breakthrough device called the IsoFlow infusion catheter. The catheter, which received 510(k) clearance in September 2009, makes it possible to direct the delivery of chemotherapy to cancerous tumors. It enables sideways perfusion, which allows physicians to precisely target and isolate areas within the body where the infused drugs are delivered.
www.vasculardesigns.com

 

Michael Yang, general manager
 

Veridex
Raritan, NJ
Annual revenue: N/A (part of J&J)
Key products: Diagnostic systems
Reason to watch: Already lauded with a Prix Galien USA Award, Veridex is making waves in diagnostics with its CellSearch System. The tool is the first diagnostic test used to automate the detection and capture of circulating tumor cells that have entered a patient’s blood. It represents a shift in managing certain types of cancers and provides oncologists with a clearer picture of the prognosis and overall survival of patients with metastatic breast, colorectal, or prostate cancer during treatment.
www.veridex.com

Howard Edelman, CEO

VitalWear
San Francisco
Annual revenue: N/A (privately held)
Key products: Therapeutic devices
Reason to watch: VitalWear is on a quest to expand its suite of low-cost, reimbursable, durable medical equipment, which is used in the orthopedic, sports medicine, and home healthcare markets. Its thermal therapy devices, such as the VitalWrap, its first product, are used to accelerate recovery and treat pain from a broad range of injuries and chronic conditions. With millions of people in the United States alone suffering from persistent pain, VitalWear is well positioned.
www.vitalwear.com

 


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