New Companies & Technologies Report · 2009. 2. 16. · New Companies & Technologies Report February 2009 NCTR ... It is intended for use as a minimally invasive, beating heart alternative

New Companies & Technologies Report February 2009

NCTRglobal survey of emerging and disruptive healthcare companies and technologies

New Companies and Technologies Report OneMedPlace Intelligence Services

Copyright © 2009. Not for redistribution. This bi-weekly report of new healthcare and life sciences technologies and companies is part of the OneMedPlace Intelligence Services, which includes access to the OMP video library and Research Reports. For subscription information, please visit: www.onemedplace.com

Issue 1 Cardious has developed an aortic valve bypass graft system, enabling surgeons to relieve stenosis and administer valve replacement therapy while the heart is still beating. Cardiology

ClearCount provides a radiofrequency Identification (RFID) system for detecting and counting surgical sponges, ensuring the complete removal of foreign bodies post‐procedure. Surgery

Echo Therapeutics is developing a needle‐free and wireless transdermal continuous glucose monitoring (tCGM) system for diabetic patients, designed to reduce reliance on the conventional finger‐prick testing system while increasing the accuracy of results. Patient Monitoring Eigen provides urologists with real‐time, multi‐dimensional (including 4‐D) imaging and navigation tools to facilitate accurate prostate biopsies. Urology GetWellNetwork offers an integrated package of software suites designed to provide an interactive in‐patient care, education and entertainment experience for patients, families, caregivers and administrators from the convenience of an in‐room television monitor. Software Systems Healionics offers a proprietary, precisely engineered biomaterial scaffold that improves the biointegration of percutaneous and implanted medical devices, thereby facilitating the healing of long‐term implants. Regenerative Medicine

Interventional Spine develops and markets percutaneous systems for the surgical treatment of the lumbar spine, including a trans‐facet compression system for posterior stabilization during lumbar fusion. Orthopedics

Lerner Medical utilizes proprietary UV‐based technology to develop cost‐effective and safe phototherapeutic treatments for skin conditions, including psoriasis. Dermatology OmNeuron utilizes functional neuroimaging technology to evaluate neural activity associated with pain awareness and to develop cognitive tools enabling patients to consciously control their perceptions of pain. Neurology Redpath Integrated Pathology offers a high throughput molecular profile system that combines genetic mutational analysis with conventional pathology analysis, enabling pathologists to analyze the acquired mutational damage implicated in cancer progression and to differentiate among various stages and types of lesions. Oncology Sleep Solutions provides at‐home diagnostic products and services for the evaluation of sleep‐disordered breathing conditions, including the only physician‐prescribed and FDA‐cleared testing device for obstructive sleep apnea. Diagnostics Zogenix develops drug‐device combinations intended to provide relief to individuals suffering from central nervous system disorders and chronic pain, including a subcutaneous sumatriptan delivery platform for the treatment of migraine and cluster headaches. Patient Monitoring

Symbol PrivateExchange PrivateFounded 2006

Employees

OneMedPlace Investment Database Company Profile

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Cardious360 North Robert Street,Suite 510St. Paul , MN USA , 55101phone: 651-789-0550fax:www.cardious.com

Research Sector Medical Devices & TechSummary DescriptionBeating Heart Alternative to Aortic ValveReplacement TherapyKeywordscardiology, cardiovascular, aortic, valve,stenosis, bypass, graftManagementJim Pokorney, President and CEO; KemSchankereli, Chief Technology Officer; PatMcCarthy, MD, Chief Medical Officer; NancyNess, Chief Financial Officer

DescriptionCardious, Inc. was established in 2006 for the purpose of providingcardiac surgeons with implants and associated tools necessary to safelyand effectively relieve aortic heart valve stenosis (narrowing orobstruction) and improve blood flow. Technology/DifferentiationLike other transcatheter heart valve systems in development, theCardious devices allow for "off pump" aortic valve replacement.Cardious' transcatheter valve technology, however, enables thecontinued use a traditional, commercially available prosthetic heartvalve. Requiring only a small incision between the ribs to expose thebeating heart, the AvA(TM) System is surgically implanted using thesystem's cutting tool, which bloodlessly connects one of the custom-designed grafts into the left ventricle and the other graft to thedescending aorta. The surgeon then inserts a commercially availableprosthetic heart valve into the titanium valve housing to form analternative pathway for blood flow away from the heart. The native valveis left intact and functioning, although the primary blood flow circulatesthrough the implanted AvA device. The company's preliminary lab testsindicated that the improvement in heart function created by the valvebypass is the same as that obtained with a traditional valve replacement. Products/ServicesCardious' intellectual property portfolio includes the AvA(TM) AorticValve Bypass Graft System. It is intended for use as a minimallyinvasive, beating heart alternative to traditional aortic valve replacementtherapy (a process that requires stopping of the heart). The patentpending implantable device is composed of two polyester grafts, titaniumvalve housing, and an associated cutting tool. Market/CustomersThe "off-pump" AvA(TM) System is intended for patients with severeaortic valve stenosis that cannot handle the rigors of traditional valvesurgery or those at high risk of experiencing serious complications afteruse of a heart-lung machine. According to market research presentedby Edwards LifeScience Inc., over 100,000 patients annually (U.S. andEurope) fall into this "no option" category. Although applicable to over90% of this market, the Cardious device will specifically target theestimated 50% of this "no option" pool not eligible for transcatheterprocedures due to one or more physiological or anatomic restraints,including significant coronary artery disease. StatusCardious is currently performing long term animal studies and isfocused on the final design, fabrication, testing, and documentationrequired to support human studies in 2010. The company is currently indiscussion with investors to raise funds sufficient to support the initialhuman studies.

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ClearCount MedicalSolutions101 Bellevue Road, Ste. 300Pittsburgh , PA , 15229phone: 412-931-7233fax:www.clearcount.com

Research Sector Medical Devices & TechSummary DescriptionRFID Tracking of Foreign Bodies during SurgeryKeywordssurgery, RFIDManagementDavid Palmer, CEO; Steven Fleck, Co-Founderand Chief Technology Officer; Curtis Groppe,Vice President of Sales and Marketing

DescriptionClearCount Medical Solutions is the only provider of a spongemanagement system that combines the benefits of counting anddetection. Counts can be quickly reconciled and, in the event ofnon-reconciliation, a missing sponge can be located using theSmartWand (TM). ClearCount's innovations bring to market acomprehensive sponge reconciliation and detection solution thatimproves patient safety and operational efficiency. Technology/DifferentiationRFID tags are tiny microchips (approximately the size of a dime) thatact as transponders listening for a radio signal sent by transceivers(RFID scanners). When a transponder RFID chip (which is permanentlysewn onto the sponge) receives a certain radio query, the spongeresponds with a unique ID code back to the scanner. The broadcastsignals from the scanner are designed to be read between a few inchesand several feet away, depending on the size and power driving theRFID tags. The SmartSponge System confirms the sponge count, whilethe SmartBucket screen highlights any count discrepancies. A quickSmartWand scan then identifies any sponges remaining in the patientand avoids the need for additional X-rays. The SmartSponge Systemutilizes a SmartMat to notify the user that the scan is going smoothly andwithout error. The SmartSponge System utilizes Texas Instruments Inc.'s"Tag-it HF-I" portfolio of high-frequency products to automate theprocess of managing surgical sponges during surgery. Products/ServicesThe SmartSponge System is ClearCount's signature product. It is theonly system to date that uses Radiofrequency Identification (RFID) todetect and count surgical sponges during surgical procedures. Thistechnology is capable of distinguishing among sponge sizes and types,as well as alerting staff members when a sponge goes missing. Staffmembers do not need to manually separate the sponges or orient theRFID tags since the system does not require "line of sight" technology(similar to that used for barcodes), thereby minimizing the handling ofsoiled materials and preserving safety for patients and staff. Market/CustomersAccording to ClearCount, retained foreign bodies currently amount toan estimated $1.5 billion in annual costs; accounting for sponges andinstruments alone costs American healthcare institutions $1 billion (aswell as fifteen to thirty minutes set aside for manual counting after eachof the nearly ten million surgical procedures performed annually). If themanual counts do not match among medical personnel, another $375million are devoted to post-procedure x-rays and (in a less-than-idealscenario) $125 million are allocated to medical malpractice suits. StatusClearCount received FDA 510 (k) clearance for the SmartSpongeSystem in June 2007 and announced its commercial launch on March31 2008. On April 1, 2008, the company announced its exclusivedistribution agreement with Cardinal Health. ClearCount's technologyhas received favorable press from numerous domestic and internationaloutlets, including the Wall Street Journal, BBC News, the New YorkTimes, Forbes, CNN and ABC News.


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Symbol ECTEExchange NASDAQFounded 1989

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Echo Therapeutics10 Forge ParkwayFranklin , MA USA , 02038phone: (508) 553-8850fax: (508) 553-8760www.echotx.com

Research Sector Medical Devices & TechSummary DescriptionNon-Invasive Transdermal Drug Delivery SystemsKeywordstransdermal medication, drugs, ultrasonic, drugdelivery, DrugDeliveryManagementPatrick T. Mooney MD, Chairman & ChiefExecutive Officer; Harry G. Mitchell, ChiefOperating Officer and Chief Financial Officer;Shawn K. Singh, JD, President

Ownership Financials

* numbers in thousands

1 QTR | 1 YR | 5 YR

Revenue Outlook

DescriptionEcho Therapeutics is a medical device and specialty pharmaceuticalcompany developing a non-invasive (needle-free) and wirelesstransdermal continuous glucose monitoring (tCGM) system for diabeticpatients. The company also possesses a pipeline of novel topicalreformulations of FDA-approved pharmaceuticals. Technology/DifferentiationEcho's Symphony tCGM System incorporates Echo's patentedfeedback mechanism for optimal skin permeation control and itsnon-invasive, continuous transdermal biosensor. AzoneTS is a non-toxicpenetration enhancer known to increase lipid membrane fluidity in thestratum corneum (outermost layer of the skin), thereby decreasing thediffusion resistance to topically applied therapeutics by two to more thantwenty fold. In addition to Durhalieve, Echo Therapeutics is developingadditional AzoneTS product candidates in accordance with the FDA'sSection 505(b)(2) guidelines. Echo's ultrasound-mediated skinpermeation technology enhances the fluids and molecules across theprotective membrane of the stratum corneum. An application ofSonoPrep increases skin permeation to one hundred times greater thanuntreated skin, facilitating the transdermal delivery of large moleculedrugs. Products/ServicesWith the Symphony tCGM, Echo Therapeutics has demonstrated itsgoal to reduce reliance on periodic point-of-care finger-stick glucosetesting by providing reliable on-demand data in a continuous, convenientand cost-effective manner. The company hopes its non-invasivetechnology will improve patient compliance and enable patients toachieve better overall glucose control day and night. Echo is alsoleveraging its patented AzoneTS transdermal drug reformulationtechnology to build a pipeline of novel topical reformulations ofFDA-approved products. Durhalieve, Echo's lead AzoneTS drugcandidate, is a topical reformulation of the corticosteroid triamcinoloneacetonide. Additionally, Echo's FDA-cleared SonoPrep usesnon-invasive ultrasonic skin permeation technology for painless andtransdermal drug delivery. Market/CustomersEcho Therapeutics primarily markets its products through independentmedical device distributors in the United States. Its Symphony tCGM isintended for home use and use within the hospital critical care sector.Diabetes is the sixth leading cause of death in the United States; over$100 billion is spent annually in the United States for the direct andindirect costs of treating diabetes. StrategyThe company intends to expand the application of its SonoPreptechnology to detect and measure other analytes, such as alcohol andother blood chemistries, that are traditionally measured by sendingblood samples to the lab for analysis. StatusEcho received FDA 510(k) marketing clearance in February 2004 forthe use of Sonoprep in electrophysiology applications. On October 16,2008, the company announced the issuance of a U.S. patent coveringthe composition and preparation methods of a polyethylene glycol(PEG)-based hydrogel, a key component of Echo's Symphony tCGMsystem. Echo announced positive results in November 2008 from itsmost recent clinical trial of the Symphony system in type I and IIdiabetic patients. Additionally, the company has submitted a New DrugApplication (NDA) covering Durhalieve as a proprietary treatment forcorticosteroid responsive dermatoses and plans to submit anInvestigational New Drug (IND) application to commence Phase 2clinical development of this drug candidate for the treatment of keloidand hypertrophic scarring.


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Eigen13366, Grass Valley Avenue,Grass Valley , CA USA ,95945phone: (888) 924-2020fax: (530) 274-3656www.eigen.com

Research Sector Medical Devices & TechSummary Description4-D Technology for Prostate BiopsiesKeywordsprostate, biopsy, imaging, 4D, cancer, ultrasoundManagementMichael Castorino, CEO

DescriptionEigen specializes in obtaining clear, high-definition views of movingimage studies. The company originated as Eigen Video, known fordeveloping the now ubiquitous 'instant replay' for football broadcasts, aswell as the cutting-edge special effects for the Star Wars trilogy. Eigenis currently applying its imaging technology to the area of prostatecancer diagnosis. Its primary offering is its ei-Nav series of products,which provides urologists with real-time, multi-dimensional imaging andnavigation tools to facilitate accurate prostate biopsies. Technology/DifferentiationThe Artemis system employs Eigen's patented ei-4D (TM) technology toconvert 2-D ultrasound into 3-D and 4-D images. During biopsy,Artemis displays the 4-D orientation and navigation of the needletrajectory, as well as the core position, depth and deflection. The volumeof the prostate can be computed automatically and displayed within sixseconds. Its Atlas/HotSpot(TM) planning feature provides the statisticalprobability of known locations based on age, ethnicity and PSA scores;a physician may utilize this tool to generate a "pre-loaded" biopsy planbased on conventional treatments or to develop a customized plan. Products/ServicesArtemis, the main product of the ei-Nav series, delivers real-time 4-Dneedle navigation, targeting and tracking for image guided biopsies.Physicians will have the visual acuity to view inside and rotate theimages in any dimension and to examine the prostate for abnormalitiesor suspicious regions that may need sampling. Moreover, theinformation from a biopsy can be recorded (including a 3-D image ofthe target tissue) and saved for future reference, treatment planning,and monitoring. This enables physicians to revisit or avoid a particulararea during subsequent biopsies. Market/CustomersProstate cancer is the second most common type of cancer found inAmerican men, affecting one in six men over the course of theirlifetimes. About 186,320 new cases of prostate cancer and nearly30,000 deaths from the disease are expected for 2008. The number ofprostate biopsies administered in the coming years is expected toincrease if urologists decide to lower the standard PSA score, thediagnostic measure that determine the necessity of a biopsy. Themarket for prostate cancer is expected to reach or exceed $709.8million in 2009. StatusEigen received FDA clearance for Artemis in May 2008 andcommenced sales of the product shortly after. The company's productsare used in over four thousand hospitals worldwide.


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Get Well Network7920 Norfolk Ave., 11th FloorBethesda , MD United States, 20814-2500phone: (240) 482-3200fax: 240.482.3201www.getwellnetwork.com

Research Sector Healthcare ServicesSummary DescriptionInteractive and Personalized Patient CareExperiencesKeywordsPatientMonitoring, Patient Monitoring, software,entertainment, patient, education, interactive,personalized careManagementMichael O' Neil, Jr, Founder and Chief ExecutiveOfficer; David Wright Chief Outcomes Officer;Robin Cavanaugh, Executive Vice President,Chief Technology Officer; Bruce Matter,Executive Vice President, Sales & ClientSatisfaction; Irwin Studen, Senior VicePresident, Chief Financial Officer; Philip Groves,Senior Vice President, Client Services andSupport; Stephen Hiscott, Senior Vice President,Business Development; John Plunkett, VicePresident, Marketing

DescriptionGetWellNetwork is a privately-held company seeking to provide acomprehensive solution to hospital patient education and entertainmentby turning an in-room television monitor into an interactive experiencefor patients, families, caregivers and administrators. Technology/DifferentiationThe PatientLife System comprises three integrated software suites forpatient resources (e.g., entertainment and connections to the outsideworld), communication (i.e., between patient and staff, among staffmembers) and care (e.g., pain assessment, educational materials).They collectively work to establish an interactive patient careenvironment and personalized care experiences for each patient. As forthe GetWellNetwork hardware, the head-end unit is composed of highperformance servers designed to support application and databaseservices, private networking, firewall protection, remote accessmonitoring and system maintenance services. The system also providessupport for redundant power supply and surge protection. Allcomponents of the system are stored in one complete full height,high-density rack unit. In each patient room, each display device (i.e.,television monitor) is equipped with a digital set-top box acting as acontroller and conduit between the GetWellNetwork Head-End Hardwareand the display device. Patients and other end users access the systemvia a pillow-speaker and accompanying keyboard for text input; remotecontrols are also offered. Products/ServicesThe PatientLife System contains three main components. First, thePatient Pathways technology streamlines and automates day-to-daypatient care processes. It consists of a variety of coordinated,automated prompts appearing on the patient's monitor to invite eachpatient, at the appropriate time, to learn more about his/her care,condition, and safety as well as other important aspects of his/herhospital visit. Standardized content packages are also included forpatient education; while hospitals still have the opportunity to includeproprietary or preferred content, the standard content packages are agreat addition to any hospital education library. Additionally, a new andimproved user interface was designed to improve the overall patientexperience and convenience of the system. Market/CustomersGetWellNetwork is currently in partnership with more than 50 thoughtleading hospitals and healthcare systems, with more than 100 PatientPathways systems deployed at client hospitals across the country. StatusGetWellNetwork announced the release of PatientLife System 3.0 inNovember 2008. Its new features include tools for executive reporting ofpatient experience data in real time, revenue generation and greaterease-of-use for consumers. As of December 2008, more than twomillion 'patient pathways' have been launched for individual patients. In2007, the GetWellNetwork solution received the exclusive endorsementof the American Hospital Association (AHA).


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Healionics14787 NE 95th StreetRedmond , WA USA , 98052phone: 425.818.1987fax: 425.284.4950www.healionics.com

Research Sector Biotech Specialty PharmaSummary DescriptionBiomaterial Solutions for Medical DevicesKeywordsregenerative medicine, biomaterialsManagementRobert Brown, MBA, CEO; Max Maginness,Ph.D.,CTO; Michel Alvarez, MBA, COO; BillEaton, MBA, CFO

DescriptionHealionics is a privately held biomaterials company whose mission is tobe the leading provider of tissue regeneration and device biointegrationsolutions to healthcare manufacturers. The company is developinginnovative biomaterial scaffolds for the purpose of enabling or improvingthe biointegration and healing of long-term implants. Technology/DifferentiationIn contrast to many porous biomaterials originally designed for otheruses (such as filtration), STAR has been specifically engineered for thepurposes of enhancing biointegration of percutaneous and fullyimplanted devices and for promoting sufficient healing. The key to STARis its tightly controlled pore geometry. Unlike other 3-D scaffolds withvarying pore sizes, STAR's precisely engineered, uniformly sized poresmaximize angiogenesis, encouraging both tissue and blood vesselingrowth while minimizing foreign body encapsulation. Products/ServicesHealionics' flagship and proprietary product, STAR (Sphere TemplatedAngiogenic Regeneration), is a precisely engineered biomaterialscaffold that improves the biointegration of percutaneous and implantedmedical devices. This material is available in a variety of shapes andsizes, including sheets, tubes, and injectable pellets. STAR can be madefrom existing medical grade substrates, including silicone, pHEMA andhyaluronic acid. Market/CustomersSTAR biomaterials are being evaluated in various implant applications,including: ophthalmic devices, advanced wound care, aestheticimplants, biosensors, obesity and diabetes management devices andpain management leads. StatusHealionics announced in December 2008 that it had raised $2.6 millionin a Series B financing from private investors. As of Septmber 2008, thecompany entered into a multi-million dollar manufacturing, supply anddistribution agreement with TR BioSurgical, LLC (TRBIO) for use of itsflagship STAR biomaterial scaffold in a veterinary glaucoma implant.Under this exclusive, multi-year agreement, Healionics will provide itsSTAR biomaterial scaffold for the development of TRBIO'sTR-ClarifEYE, an innovative implant for the treatment of glaucoma inanimals planned for limited market launch in the first quarter of 2009.The company has signed sixteen commercial research agreements forSTAR biomaterial and has an exclusive license to breakthroughbiocompatibility technologies created by the University of WashingtonEngineered Biomaterials group (UWEB) over a 9-year period with $30million in funding as a US National Science Foundation EngineeringResearch Center (NSF ERC).


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Interventional Spine13700 Alton Parkway, Suite160Irvine , CA United States ,92618phone: (949) 472-0006fax: (949) 472 0016www.i-spineinc.com

Research Sector Medical Devices & TechSummary DescriptionMinimally Invasive Percutaneous Technology toTreat Lower Back PainKeywordspercutaneous, back surgery, lumbar spine, backpain, medical devices, implant, orthopedicsurgeon, neurological surgeonsManagementWalter A. Cuevas, Chief Executive Officer;Thomas R. Brown, Vice President, EmergingMarkets; Andrew Caudell, Managing Director,Europe, Middle East and Africa; Brad Culbert,Chief Technology Officer; Klaus L. Dahmen,Vice President, US Sales; Carol Emerson, MBA,Vice President of Quality and Logistics; Harold A.Hurwitz, Vice President and Chief FinancialOfficer; Dennis Sellke, Senior Vice PresidentMarket Development & Marketing

DescriptionInterventional Spine, Inc. is a medical device company exclusivelyfocused on the development and marketing of its patented percutaneoussystem to treat lower back pain. This less-invasive intervention isintended to bring back pain patients relief earlier in the treatmentcontinuum, minimize patient trauma, lower complication rates andshorten procedure times. Technology/DifferentiationThe PERPOS PLS System, including the unique BONE-LOK PLSImplant, enables fusion by providing secure bilateral immobilization ofthe facet joints. The PERPOS Fusion Facet Kit, when used withInterventional Spine's PERPOS PLS System, is intended to enableclinicians to roughen the facet joints prior to stabilization and to placebone graft material in the surrounding area (if desired). The systemensures precise over-the-wire guidance of all instruments and implants,as well as stable fixation without cumbersome rods and screws. ThePERPOS PLS System requires one fifteen millimeter incision using theTeleport Tissue Retractor, making it one of the least invasive treatmentsavailable. Products/ServicesThe PERPOS PLS System is the first and only percutaneous transfacet-pedicular compression system to date for posterior stabilization during afusion procedure of the lumbar (lower) spine. The PercuDyn System,cleared for use outside of the United States, is a percutaneous bilateralfacet augmentation system for treating degenerative disc disease(DDD), lumbar spinal stenosis and facet pain. Market/CustomersAccording to the National Library of Medicine, almost 30 millionAmericans are afflicted by lower back pain at any point in time while anestimated 85% of Americans will experience back problems at somepoint in their lives. The remaining 5-10% of individuals suffering fromdisabling conditions which may ultimately lead to surgery; estimatesplace the number of Americans suffering from disabling back pain atany given time at approximately 3 million. The market is expected toexpand to over $15.6 billion by 2015. StatusInterventional Spine announced in October 2008 that it had entered anagreement with Dr. Rudolf Morgenstern for the acquisition of allintellectual property, product prototypes and test data of Dr.Morgenstern's Percutaneous Nucleus Scaffolding System (PNSS).When used with Interventional Spine's existing PercuDyn System,PNSS can facilitate a completely percutaneous procedure intended toreplace the current highly invasive procedure involving open surgicalimplantation of artificial spinal discs. As of July 2008, the company hasimplanted over 6,000 patients with (and trained 400 physicians in) itspercutaneous spine therapy technologies since introducing its productline less than two years ago. The company also announced that theFDA granted conditional investigational device exemption (IDE) approvalfor its PercuDyn System.


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Lerner Medical1545 Sawtelle Blvd., Suite 36Los Angeles , CA USA ,90025phone: (310) 914-0091fax: (310) 914-0095www.lernermedical.com

Research Sector Medical Devices & TechSummary DescriptionUV Phototherapy to treat Psoriasis and otherPhotoresponsive Skin ConditionsKeywordsphototherapy, UV, psoriasis, dermatologyManagementEthan Lerner, M.D., Ph.D., Chairman; John R.Lyon, BA, President and CEO; ZafirisGourgouliatos, Ph.D., Chief Technology Officer,and a Company co-founder; David Chang,BSME, Vice President

DescriptionLerner Medical Devices, Inc. uses its proprietary UV phototherapytechnology to develop, manufacture and market medical devices for thetreatment of skin conditions and diseases. Technology/DifferentiationLerner Medical utilizes advanced HIFOL (High Intensity Fiber OpticLight) optical technology to provide phototherapeutic approaches to skinconditions and disease. Employing a patented quartz fiber-optic UV lightdelivery mechanism, the Lumera Targeted PhotoTherapy Systemdelivers concentrated and targeted doses of ultraviolet light (UVB) topsoriasis-affected skin at a therapeutic intensity only previouslyavailable in physician office systems. The Lumera System is comprisedof the general purpose Lumera Beam (LiteSpot Treatment Beam) fortreating psoriasis on the body and the special purpose Lumera Brush(LiteBrush Treatment Comb) for scalp treatment. The Lumera LightSource emits the therapeutic UVB light that powers the Lumera Brushand the Lumera Beam; advanced optical technology filters the energygenerated by a proprietary UVB enhanced lamp and emits light in thetherapeutic UVB band (290 to 320 nanometers). Products/ServicesThe company's portfolio includes the office-based Levia TargetedPhototherapy System (currently marketed under the Lumera brand) andthe Levia Home-Use PhotoTherapy System for the phototherapeutictreatment of scalp and small-area psoriasis. The company aims tobecome a market and technology leader in developing and supplyinghigh-intensity, targeted phototherapy devices for the treatment ofpsoriasis and other photoresponsive skin diseases (including eczema,seborrheic dermatitis and vitiligo). The potential benefits of thecompany's phototherapy systems include: less expensive andtime-consuming treatment options for psoriasis patients, as well as thelack of detrimental side effects associated with prolonged steroid use ormajor organ toxicity hazards associated with systemic and/or biologicaltreatment options. Market/CustomersOver six million people in the United States suffer from psoriasis, achronic inflammatory condition characterized by red scaly patches onthe skin that may be associated with itchiness, pain, and bleeding.About 80% of these individuals have a mild or moderate skin disease forwhich the company's products are indicated. More than $5 billion arespent annually on prescription drugs and physician services in theUnited States to treat psoriasis. According to a survey from the NationalPsoriasis Foundation (2002), many psoriasis patients were unsatisfiedwith treatment and often ceased their therapy. Patients, physicians andthird-party payers are actively looking for a better way to treat psoriasis. FundingTo date, Lerner Medical Devices, Inc. has financed its operations withan initial angel-financing round of $1.3 million augmented by $0.8 millionin SBIR research grants to support product development and efficacystudies. This initial funding has been followed by the company's start-upfinancing round of $3.3 million closing in December 2007. StatusThe Lumera System received FDA 510(k) clearance and CE approval.Lerner Medical has licensed its technology to the Daavlin Company forworldwide manufacturing and distribution. The company will apply forFDA 510(k) clearance and CE Marking in early 2009 for its LeviaHome-Use PhotoTherapy System and expects regulatory clearancemid-year. Lerner is currently seeking an additional $10 million in equitycapital to accomplish the following: to fund its initial marketing and salesefforts in the United States, Europe and Japan; to fund manufacturingramp-up (including tooling and initial inventory build); to supportpost-launch research & development efforts; and to supply cash for thecompany's general working capital needs.


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Omneuron99 El Camino RealMenlo Park , CA USA ,94025phone: 650 585-5301fax: 650 327-7536www.omneuron.com

Research Sector Medical Devices & TechSummary DescriptionReal-time Functional MRI Technology to ModifyCognitive Perception and Treat Chronic PainKeywordsimaging, neurology, psychiatry, brain, pain,chronic pain, fMRI, functional MRI, addiction,depressionManagementChristopher deCharms, M.D., President andCEO

DescriptionOmneuron is a life sciences company focusing on novel MRItechnologies. It is developing applications of functional neuroimaging,including non-invasive technology to measure and direct brain functionin real time. Technology/DifferentiationOmneuron's chronic pain study patients are exposed to a novel form ofcognitive training for controlling pain. Participants are scanned usingfunctional MRI while they employ cognitive strategies allowing theparticipant to view and mediate their brain activity. A clinical trial sessionproceeds as follows: A patient slides into the coffin-like scanner andwatches a computer-generated flame projected on the screen of virtual-reality goggles. The flame's intensity reflects the neural activity ofregions of the brain involved in the perception of pain. Using a variety ofmental techniques (for instance, imagining that a painful area is beingflooded with soothing chemicals) most people can make the flame wanewith little concentration; a waning flame indicates that the patient isfeeling better. Products/ServicesSuperficially similar to an older technology, electroencephalogrambiofeedback, which measures electrical feedback across multiple areasof the brain, fMRI feedback measures the blood flow in precise areas ofthe brain in real time. This technology can shed insight on the particularregions involved in processing different feelings or tasks. Omneuron iscurrently evaluating activity in the region of the brain involved inmediating awareness of pain, the rostral anterior cingulate cortex(rACC), and developing cognitive tools enabling patients to consciouslycontrol their perceptions of pain. Market/CustomersAt least $80 billion dollars is spent for pain relief in the United Stateseach year, a significant amount allocated for prescription medicationswith short-lived relief and/or a high potential for addiction. Thecompany's technology will be available in the clinical and researchdomains. StatusIn addition to conducting its smoking cessation and chronic pain clinicaltrials, Omneuron is also researching treatments for addiction,depression and other psychological illnesses. The company is alsoinvestigating the use of fMRI in improving athletic performance.Omneuron's use of real-time functional MRI technology for painmanagement has been published in leading scientific journals (PNAS)and featured in the mainstream press (NY Times). The company is inthe process of commercializing its technology.


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RedPath IntegratedPathology2515 Liberty AvenuePittsburgh , PA USA , 15222phone: 412-224-6100fax: 412-224-6425www.redpathip.com

Research Sector Healthcare ServicesSummary DescriptionAdvanced Laboratory Services for IndeterminateOncology CasesKeywordsgenomics, cancer, diagnostics, oncologyManagementSydney D. Finkelstein, Chief Scientific Officer;Joseph Donnelly, CFO; David J. Haffner, ChiefOperating Officer; Elaine M. Elder, Sc D, VicePresident, Clinical Operations; Ernest C. Jacobs,Vice President, Technical Operations;

DescriptionRedPath is a CLIA certified and CAP accredited commercial laboratorythat integrates molecular DNA analysis with conventional pathologyreview. The company provides early and definitive cancer diagnosticsupport for pathologists and clinicians faced with diagnostic dilemmas orinconclusive results from standard testing. Technology/DifferentiationRedPath's PathfinderTG is built on a proprietary, patented TopographicGenotyping platform, a high throughput molecular profiling system.PathFinderTG focuses on the temporal sequence of acquired mutationaldamage rather than inherited genetic predisposition for certaindiseases. Acquired mutational damage, as opposed to tumorinvasiveness, has been implicated in the metastasis and aggressivenessof various cancers. This fusion of quantitative genetic mutationalanalysis with pathology analysis can deliver unprecedented diagnosticaccuracy when differentiating between reactive versus neoplasticlesions, grades of dysplasia, benign versus malignant lesions,metastatic, synchronous and recurrent tumors and biologically indolentversus aggressive tumors. The company uses a broad panel of geneticmarkers, microdissection techniques and proprietary DNA amplificationmethods to produce unique information about cancer progression ineach patient. Products/ServicesPathFinderTG is a patented advanced testing platform for resolving"indeterminate, atypical, suspicious, equivocal and non-diagnosticspecimen" diagnoses from the original pathology specimen. Dependingon the type of tumor, this technology provides clinicians with theinformation necessary for them to make subsequent treatment decisions(i.e., surgery, chemotherapy, radiation therapy, re-evaluation of benigntumors). Market/CustomersThe market for cancer diagnostics will reach $7.4 billion by 2009 and isexpected to increase as more cancer cases are diagnosed.Approximately 1.4 million individuals in the United States are diagnosedwith cancer annually. StatusIn October 2008, RedPath Integrated Pathology received the PittsburghTechnology Council Tech 50 Award in Life Sciences. The companyclosed a $3 million round of financing in May 2008, and announced InJune 2007 that PathFinderTG was approved by Highmark MedicareServices for reimbursement coverage.


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Sleep Solutions, Inc.801 Cromwell Park Drive,Suite 108Glen Burnie , Maryland USA ,21061phone: 877-753-3775fax:www.sleepsolutions.com

Research Sector Medical Devices & TechSummary DescriptionDiagnostic Service Provider of Home Testing andEvaluation of Sleep-Disordered BreathingKeywordsSleep-disordered breathing, NovaSom,Home-diagnostic system, MediTrack System,Digital-signal processing technologyManagementMichael J. Thomas, President and CEO; GaryCorbett, CIO and VP Operations; Jan Barker,Chairman of the Board

DescriptionSleep Solutions, Inc. (SSI) is a private diagnostic service provider ofhome testing and evaluation of sleep-disordered breathing conditions,including obstructive sleep apnea (OSA). Technology/DifferentiationTo date, NovaSom QSG is the only physician prescribed device clearedby the FDA that is specifically designed for unattended and unassisteduse in the patient's home and clinically validated against in-laboratorypolysomnography (PSG), the current standard in OSA diagnosis. Thedevice consists of a patient module worn on the wrist, a bedside unit, anairflow sensor worn on the face, an effort sensor worn around the chestand a finger sensor. NovaSom QSG utilizes patented audio digital signalprocessing (DSP) technology to sense, analyze and process thepatient's respiratory sounds and to convert these sounds to airflowvolume. The back end of this process is the Sleep Solutions StudyViewer, an electronic analysis system utilizing proprietary algorithms forautomated scoring and generation of concise yet conclusive diagnosticreports. The NovaSom QSG service is enhanced by the company'sproprietary MediTrack System, a comprehensive health caremanagement system for the direct-to-patient delivery of testing servicesand medical products. Products/ServicesNovaSom QSG enables patients to undergo testing for OSA in thecomfort and convenience of their homes, while offering physicians anexpeditious, cost-effective and accurate alternative to in-laboratory sleepstudies. Sleep Solutions' MediTrack System provides secure patient-reported health information and outcomes tracking services to aidtherapeutic decisions and disease state management. SSI's at-homepulse oximetry service facilitates the required testing of Medicarepatients receiving oxygen at home; it delivers simple and clinically-accurate overnight pulse oximetry devices to patients' homes andprovides instruction on how to operate the devices. The devices are thenreturned to SSI's Medicare-approved Independent Diagnostic TestingFacility (IDTF). Market/CustomersOSA is a serious and potentially life-threatening sleep disorder affectingas many as 18 million Americans; as many as 85% of individuals withsleep apnea are currently undiagnosed. The OSA diagnostic testingmarket is projected to exceed $3 billion by the end of 2008 and isexpected to grow at an annual rate of 20-30% until 2013. Competitors/Substitutes/AlternativesThe standard method for diagnosing OSA requires placing the patient ina sleep laboratory overnight and performing polysomnography (PSG).This process is expensive, ranging from $1,000 to over $2,500 pernight. The estimated 2,200 sleep laboratories in the U.S. can onlyaccommodate a fraction of the patients that require diagnosis. Patientsoften resist submitting to this uncomfortable and expensive procedure. StatusSleep Solutions announced that it had secured $20.5 million inadditional venture funding from the TPG Biotechnology II fund in March2008. NovaSom QSG is currently available with a prescription and isfully reimbursable by most U.S. health insurance firms.


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Symbol PrivateExchangeFounded 2006

Employees 47


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Zogenix12671 High Bluff Drive, Suite200San Diego , CA USA , 92130phone: 858-259-1165fax: 858-259-1166http://www.zogenix.com

Research Sector Medical Devices & TechSummary DescriptionDrug-Device Combinations to Treat Chronic PainKeywordsdrug delivery, pain, CNSManagementRoger L. Hawley - Chief Executive Officer andDirector; Stephen J. Farr- President, ChiefOperating Officer and Director

DescriptionZogenix is a specialty pharmaceutical company established in August2006. The company is developing drug-device combinations intended toprovide relief to individuals suffering from CNS and pain disorders. Technology/DifferentiationZogenix's proprietary DosePro technology is a subcutaneousneedle-free drug delivery system enabling self-administration ofpre-filled single doses of liquid drug formulations. According to thecompany, the benefits of Dosepro include: less anxiety or fearregarding injections, its easy-to-use three step process, discreetportability, and easy disposal. This device can also deliver various typesof therapeutic compounds, including small molecules and highly viscousmaterials. Products/ServicesSumatriptan DosePro is a drug-device combination that subcutaneouslydelivers sumatriptan for the treatment of migraine and clusterheadaches. The company envisions sumatriptan DosePro will serve as areplacement for other injectable forms of sumatriptan and as a moreefficacious alternative to tablet and nasal triptans. ZX002 is aproprietary, orally-administered version of hydrocodone used for thetreatment of moderate to severe chronic pain in patients requiringcontinuous opioid therapy. This therapy offers a controlled-releaseprofile combining immediate and extended release properties,employing the proprietary Spheroidal Oral Drug Absorption System fromElan Pharma International Ltd. (SODAS). Market/CustomersThe company's technology presents significant market potential acrossa broad range of therapeutic applications involving small volumeinjectable products, such as hepatitis, infertility, multiple sclerosis andrheumatoid arthritis. StatusZogenix is currently awaiting FDA approval for sumatriptan DosePro,and pending this decision, intends to launch its product in the firstquarter of 2009. The company anticipates initiating the Phase 3 clinicalprogram for ZX002 in the first half of 2009, which will evaluate the safetyand efficacy of ZX002 for the treatment of moderate to severe chronicpain. On July 25, 2008, Zogenix announced that it had closed an $18million financing with Oxford Finance Corporation and CIT HealthcareLLC.


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