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Posts Tagged ‘Medical Device’

Orlando medical device company AOI nabs $2.9M of $5.6M offering

Tuesday, April 19th, 2011

AOIORLANDO, FL – AOI Medical Inc., a startup developing a medical device to treat vertical compression fractures, has raised $2.92 million of a $5.62 million offering, according to a regulatory filing.

AOI is a pre-revenue, development stage medical device company focused on the development and commercialization of innovative orthopaedic medical devices for the spine and trauma markets.

The company says its strategic objective is to develop innovative orthopaedic devices that allow clinicians to utilize improved and minimally invasive approaches for orthopaedic reconstruction.

AOI says it expects FDA 501(k) clearance to marekt Ascendx this year (2011).

The company disclosed the financing in a filing with the U.S. Securities and Exchange Commission.

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Georgia’s SoloHealth injects $4M for health screening kiosks

Tuesday, April 5th, 2011

SoloHealthDULUTH, GA – Solohealth, which has developed self-service health screening and information kiosks, has raised $4 million in a mixed securities offering, according to a regulatory filing.

The company was awarded a $1.2 million National Institutes of Health grant in June last year. Founded in 2007, it  previously raised about $2.8 million from private investors.

SoloHealth presented at TechMedia’s 2010 Southeast Venture Conference.

SoloHealth’s Health and Wellness kiosks represent a new approach in publicly available, self-service health-screening. The kiosks are data-centric and use a combination of interactive health screening software and self-reported health information to produce individualized reports for consumers.

The customized reports also provide information on prevention, coupons for relevant products and services as well as doctor referrals to drive consumers to follow-up care and treatment.

SoloHealth’s EyeSite kiosk, which provides free vision screening, is already deployed in high-traffic retail locations like Kroger and Schnucks in seven markets including Atlanta, Birmingham, Houston, St. Louis, Richmond, Madison, WI and Salt Lake City.

Nearly 100 EyeSite kiosks are providing vision screening for more than 400,000 people to-date. Significantly, 25 percent of users reported never previously having had an eye exam.

The company disclosed the funding in a filing with the U.S. Securities and Exchange Commission.

 

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Dilon Technologies nabs $875K of $1.5M offering for medical imaging devices

Thursday, March 31st, 2011

DilonNEWPORT NEWS, VA – Dilon Technologies Inc., a medical imaging solutions company, has raised $875,000 from a $1.5 million mixed securities offering, according to a regulatory filing.

According to the filing with the U.S. Securities and Exchange Commission, 39 investors purchased securities. The company raised $2.2 million from nearly 200 investors in April 2010.

Dilon Diagnostics designes, makes and sells medical imaging solutions based on cooperative R&D with the U.S. Department of Energy’s Thomas Jefferson National Accelerator and medical universities. Its Dilon 6800 is a high resolution compact gamma camera that images small body parts: breast, thyroid, spot bone scans.

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Bioptigen raises $1.5M for optical imaging system

Tuesday, March 8th, 2011

BioptigenRESEARCH TRIANGLE PARK, NC – Bioptigen Inc., a company that has developed in vivo optical imaging systems that enables real-time, noninvasive imaging of internal tissue microstructure, has raised $1.5 million from a single investor, according to a regulatory filing.

Bioptigen is a spin-out of the Duke University Biomedical Engineering Department. Bioptigen was incorporated in North Carolina in August, 2004, to commercialize technologies originating in the laboratories of Professor Joseph Izatt.

The company’s technology is based on the science of Optical Coherence Tomography, an imaging system similar in function to ultrasound, but using low-power light rather than sound waves.

OCT offers resolution 100-times finer than standard ultrasound, suitable for analyzing tissue microstructure with features smaller than 4 micrometer.

Bioptigen sold $542,500 in mixed securities in 2007.

The company disclosed the current raise in a filing with the US Securities and Exchange Commission.

TechJournal South is a TechMedia company. TechMedia presents the annual conferences:

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Elenza nabs $24M financing for auto-focusing lens tech

Tuesday, February 8th, 2011

ElenzaROANOKE, VA - ELENZA Inc., a company developing the world’s first Electro-active AutoFocal Intraocular Lens, has raised $24 million Series B round of financing from from its original investors, The Carlyle Group, Washington, DC, and Delphi Ventures, Menlo Park, CA,, as well as new investors, the Itochu Corp., Tokyo, Japan and a strategic corporate investor from the ophthalmic industry.

The company says the funds will be used to support the clinical development and technology commercialization of ELENZA’s patented Electro-active AutoFocal Intraocular Lens to address the cataract extraction market and future opportunities associated with the correction of presbyopia. This capital placement is also expected to fund clinical and regulatory activities required to obtain CE mark in Europe and other international markets.

The comany competes in the multi-billion dollar IOL market for the correction of near, intermediate and distance vision. Its Electro-active Accommodating IOLs use a proprietary combination of chemistry, electricity, and integrated-circuitry to create smart optics, which will provide patients with the ability to see more naturally and clearly over a range of vision.

The technology includes an Electro-active switchable optical element that automatically adjusts focusing power electronically, in milliseconds, to maintain constant in focus vision for various working needs and/or light environments. The lens is controlled by a micro-sized power-cell with an expected 50+ year rechargeable cycle life.

South Korean firm invests $4M in BioHeart

Monday, January 24th, 2011

BioheartSUNRISE, FL – Bioheart, Inc. (OTCBB:BHRT) has entered into an agreement with AnC Bio Holdings Inc., a South Korean biomedical company, and one of its U.S. agents for a $4 million equity investment. Bioheart has designated proceeds from the investment to advance the current clinical evaluation of its cell therapies for treating heart failure and related cardiac diseases.

Bioheart, Inc. founded in 1999 seeks to be the “go to technology partner for heart failure specialists and their patients”. The company’s flagship product MyoCell is an adult muscle stem cell composition, also known as immature myoblasts, derived and processed from patient’s own thigh muscle.

Virginia-based Innocoll implants $5.25M financing

Monday, December 13th, 2010

microscopeASHBURN, VA - Innocoll Holdings Inc.,  a global pharmaceutical company selling topically applied healthcare products and surgical implants, has raised $5.25 million via a mixed securities offering, according to a regulatory filing.

The company raised $4 million selling mixed securities in 2009 and a $30 million A round of financing in 2007 led by Camulos Capital, with participation from Newsmith Capital Partners and Morgan Stanley.

It disclosed the current offering in a filing with the US Securities and Exchange Commission.

Innocoll focuses on the development of biodegradable surgical implants and topically applied healthcare products. It develops, makes and sells its  products globally.

Its  pipeline includes the CollaRx Gentamicin Surgical Implant, and a drug to treat and prevent surgical site infections; and CollaGUARD/Collieva, a drug for the treatment of ulcers, burns, split-skin donor sites, and other dermal wounds requiring temporary dermatoplasty.

The company’s Web site appears to be under construction.

Email TJS Editor Allan Maurer: Allan at Techjournalsouth dot com.

NC-based Centice near close on $1.3M round for drug verification tech

Tuesday, November 16th, 2010

CenticeMORRISVILLE, NC – Centice Corp., has received $1.22 million of a targeted $1.3 million equity raise from two investors, according to a regulatory filing.

The investment follows a $1.82 million equity raise in April. The company disclosed both financings in filings with the US Securities and Exchange Commission. SEC filings not infrequently lag actual closings of the full amounts of investments.

In 2009, Centice, a Duke University spinout founded in 2004, raised a $6.1 million C round with new investor Fulcrum Financial Group. Other   backers include The Aurora Funds Inc., Russian-based S-Group Direct Investments, Innovation Ventures, Novak Biddle Venture Partners, and several individuals. The company raised about $18 million previously through equity and debt.

Centice says its PASS Rx technology is the first and only product that utilizes patented spectroscopy and machine vision sensor technologies to confirm the accuracy of a pharmacy’s dispensed solid dose medications in a matter of seconds. Pharmacy errors in dispensing drugs are all too common and cause as many as 7,000 deaths every year.

The problem is compounded by a national shortage of pharmacists, industry groups say.

Centice technologies have additional applicability beyond just the verification of solid medications in the pharmacy, and the company has plans to develop future products for solid drug identification, liquid medication verification and counterfeit drug detection.

Scott Albert, managing general partner of Centice investor The Aurora Funds, based in the Research Triangle Park, heads the firm as CEO and chair.

Previoulsy on TechJournal South:
Centice Wants to Stop Pharmacy Errors

NC-based medical device firm nContact closes on $16M

Wednesday, November 10th, 2010

nContactMORRISVILLE, NC – Medical device firm nContact Surgical has closed on $16 million in funding led by existing investor Harbert Venture Partners. New investor ZMV Associates also participated in the round. TechJournal South reported the company had raised $13.1 million of the round in October.

According to a filing with the US Securities and Exchange Commission, the round was originally targeted at $23 million.

The company raised a total of $42.4 million across four rounds of funding.

Investors in the company, which raised a $4.4 million mixed securities round in August and a $4.8 million equity round in 2009, include: Hippo Ventures, Raleigh, NC; Intersouth Partners, Durham, NC; Harbert Management Corp., Birmingham, AL; Village Ventures, Williamstown, MA; Tall Oaks Capital, Charlottesville,VA; Massey Burch Capital Corp., of Nashville, TN; and Finistere Ventures, San Francisco.

The Morrisville, NC-based company was founded in 2005 to develop and investigate medical devices for the minimally invasive treatment of heart arrhythmias.

Its  Numeris Coagulation System with VisiTrax integrates suction, perfusion, and RF energy to create visible, non-conductive, bi-atrial, epicardial lesions on a beating heart. The tethered device is used in open chest concomitant procedures (see photo).

nContact has initiated clinical studies for the treatment of AF in both open and closed chest procedures. It is currently enrolling patients in a series of clinical trials to evaluate the use of its system for the treatment of atrial fibrillation.

NC-based nContact Surgical sews up more than half of $23.1M in equity

Wednesday, October 27th, 2010

An nContact medical deviceMORRISVILLE,  NC – nContact Surgical, formerly known as Ablatrics Inc., has rasied $13.15 million of a targeted $23.15 million equity raise, according to a regulatory filing. nContact makes medical devices for the endoscopic treatment of heart arrhythmias.

Investors in the company, which raised a $4.4 million mixed securities round in August and a $4.8 million equity round in 2009, include: Hippo Ventures, Raleigh, NC; Intersouth Partners, Durham, NC; Harbgert Management Corp., Birmingham, AL; Village Ventures, Williamstown, MA;’ Tall Oaks Capital, Charlottesville,VA; Massey Burch Capital Corp., of Nashville, TN; and Finistere Ventures, San Francisco.

It raised a total of $24 million in rounds previous to those cited. It disclosed the latest raise in a filing with the US Securities and Exchange Commission.

It’s generally a good sign when a company attracts  backing from both East and West Coast venture firms.VCs like medical device firms because the need for their products is frequently obvious and acute and they bring them to market much faster than pharmaceutical companies can get drugs approved.

The Morrisville, NC-based company was founded in 2005 to develop and investigate medical devices for the minimally invasive treatment of heart arrhythmias.

Its  Numeris Coagulation System with VisiTrax integrates suction, perfusion, and RF energy to create visible, non-conductive, bi-atrial, epicardial lesions on a beating heart. The tethered device is used in open chest concomitant procedures (see photo).

nContact has initiated clinical studies for the treatment of AF in both open and closed chest procedures. It is currently enrolling patients in a series of clinical trials to evaluate the use of its system for the treatment of atrial fibrillation.

To contact TechJournal South Editor & Writer Allan Maurer: Allan at TechJournalSouth dot com.

Raleigh’s VesOcclude Medical wraps up $1.28M raise

Wednesday, October 6th, 2010

VesoccludeRALEIGH, NC – VesOcclude Medical, a medical device company, has raised $1.28 million in equity from 10 investors, according to a regulatory filing.

It makes ligation clips for a number of medical applications. Ligation clips are V-shaped clips made from stainless steel, platinum, titanium, or an absorbable material, used to tie off bleeding vessels.

The company previously raised $1.1 million in 2009, according to filings with the US Securities and Exchange Commission, which also disclosed the current raise.

St. Jude Medical investing $60M in Atlanta’s CardioMEMS

Wednesday, September 8th, 2010

CardiomemsATLANTA – St. Jude Medical Inc. (NYSE:STJ), a medical device firm, has agreed to invest $60 million in equity in Atlanta’s CardioMEMS, which has developed a wireless sensing and communication tech to assess cardiac performance.

The agreement provides St. Jude Medical an immediate 19 percent ownership in CardioMEMS and the exclusive option to acquire the company for an additional payment of $375 million during the period that extends through the completion of certain commercialization milestones.

CardioMEMS’ wireless monitoring technology can be placed directly in the pulmonary artery to assess cardiac performance via measurement of pulmonary artery pressure, a commonly used measurement to assess heart failure. The implant procedure, the company says, is fast, simple and can be performed by any physician who does right-heart catheterizations.

With CardioMEMS’ technology, doctors can obtain this critical information without the need for a cardiac catheterization. Patients can transmit these readings from their homes, and with this vital information, physicians can more effectively direct treatments to keep patients out of the hospital.

“Technologies that help improve the management of heart failure can not only provide meaningful benefits for patients, but can also do so in a cost effective manner that is particularly important given recent health care reform in the U.S. and the attention to health care costs worldwide,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division.

Medical device firm nContact implants $4M round

Friday, August 20th, 2010

nContactMORRISVILLE, NC – Medical device company nContact has closed on a $4 million mixed securities offering, according to a regulatory filing. The company makes devices for the minimally invasive treatment of heart arrhythmias.

Investors include Harbert Management Corp., Birmingham, AL; Hippo Ventures; Finistere Ventures, San Diego; Village Ventures, Williamstown, MA; Tall Oaks Capital, Charlottesville, VA;’ Massey Burch Capital Corp., Nashville, TN; and Intersouth Partners, Durham, NC.

The company, founded in 2005, raised at least $24 million in three previous rounds.

On its web site, the company says, “We are currently enrolling patients in a series of clinical trials to evaluate the use of this system for the treatment of atrial fibrillation (AF) in concomitant procedures as well as in convergent procedures, which combine the best techniques of Cardiovascular Surgeons and Electrophysiologists to potentially provide a truly minimally invasive treatment solution for all AF patients in a single procedure.”

The company disclosed the raise in a filing with the US Securities and Exchange Commission.

To contact TechJournal South Editor & Writer Allan Maurer: Allan at TechJournalSouth dot com.

LensAR focuses in on $7M of $12M equity round

Monday, August 2nd, 2010

LensarWINTER PARK, FL – LensAR Inc. has nabbed $7 million of a $12 million equity raise for a laser-based eye treatment system, according to a regulatory filing. Investors cited in the filing with the U.S. Securities and Exchange Commission include Aisling Cpaital of New York, and MA-based Extera Partners.

In 2009 the company raised more than $7.5 million in two offerings.

Randy Frey, CEO, writes on the company Web site that “The LensAR approach is to bring the accuracy and precision of lasers into the operating room to replace blades and greatly reduce, if not eliminate, the need for ultrasound power to perform the majority of cataract removals.”

To date, according to the company, the LensAR laser system has been successfully used in well over a hundred eyes outside of the US, and is actively under review with the FDA for approval for use in the United States.

Contact Tech Journal South Editor and writer Allan Maurer: Allan at TechJournalSouth dot com.

HIFU heats up with $1M of $10M offering for prostate cancer treatment

Thursday, July 29th, 2010
HIFU device

HIFU ultrasound device

CHARLOTTE, NC – US HIFU, a  firm that has developed a treatment for prostate cancer that uses ultrasound to kill cancer cells with heat, has raised $1 million of  a $10 million equity offering, according to a regulatory filing.

The company’s treatment evolved from a technology developed in Europe. The company is headquartered in Charlotte, NC.

In 1989, three  European research groups initiated a project to develop an efficient and non-surgical treatment for localized prostate cancer. After ten years of development Ablatherm HIFU was approved for treatment in Europe.

At present, Ablatherm HIFU is being used throughout Europe, Russia and other Asian countries. To date, the company says that thousands of patients have been treated successfully in many European centers. It also provides the treatment at a Cleveland Clinic in Toronto.

The treatment uses an ultrasound probe to heat prostate cells to 185 degrees (F), killing them. It is effective on stages T1 and T2, which are also curable by radiation or surgery.

US HIFU is managing FDA clinical trials of its Sonablate 500 medical device. One trial is for primary prostate cancer and another is for patients who had radiation treatment failure.

The company dislcosed the offering in a filing with the U.S. Securities and Exchange Commission, which sites four investors.

Principals cited in the filing include David Jahns, of Galen Partners, a health–care growth-equity investment firm in Stamford, CT; George Suarez, co-foudner of US HIFU,; Arie Belldegrun, of the University of California-LA Institute of Urologic Oncology; and Lawrence Scott, a partner in the Charlotte law office of Nelson Mullins Riley & Scarborough. CEO Stephen Puckett Jr. and Chair Stephen Puckett Sr. are also listed.

Will robot surgeons replace doctors for some operations?

Wednesday, July 21st, 2010
Kaicheng Liang, part of the Duke team

Kaicheng Liang

DURHAM, NC – Next generation robots may eliminate the need for surgeon guidance during some surgeries, say Duke University bioengineers who conducted feasibility studies that demonstrated that an unassisted robot could perform certain operations.

The studies demonstrated that a robot could, without human assistance, locate a lesion in simulated human organs, guide a device to it and take multiple samples.

“Earlier this year we demonstrated that a robot directed by artificial intelligence can on its own locate simulated calcifications and cysts in simulated breast tissue with high repeatability and accuracy,” said Kaicheng Liang. a former student in the laboratory of Stephen Smith, director of the Duke University Ultrasound Transducer Group at the Pratt School of Engineering and senior member of the research team.

“Now we have shown that the robot can sample up to eight different spots in simulated human prostate tissue,” Liang told Richard Merritt for a Duke News Service article.

An earlier study reported in the January issue of the journal Ultrasound in Medicine and Biology described the Duke team’s results on simulated breast tissue. In both experiments, whole turkey breasts were used. Raw turkey breasts are commonly used in medical research because the tissue closely resembles that of humans in texture and density, and appear similar when scanned by ultrasound.

The Duke team combined a “souped-up” version of an existing robot arm with an ultrasound system of its own design. The ultrasound serves as the robot’s “eyes” by collecting data from its scan and locating its target. The robot is “controlled” not by a physician, but by an artificial intelligence program that takes the real-time 3-D information, processes it and gives the robot specific commands to perform.

The robot arm has a mechanical “hand” that can manipulate the same biopsy plunger device that physicians use to reach a lesion and take samples.’

Duke reseachers say they believe routine medical procedures, such as biopsies in other tissues in the body, will be performed in the future with minimal human guidance, and at greater convenience and less cost to patients.

An important challenge to be overcome is the speed of data acquisition and processing, though the researchers are confident that faster processors and better algorithms will address that issue. To be clinically useful, all of the robot’s actions would need to be in real time, the researchers said.

SafeStitch Medical closes on $5M funding

Friday, June 18th, 2010

SafeStitchMIAMI – SafeStitch Medical Inc., a Miami-based  medical device company primarily developing endoscopic and minimally invasive surgical devices (OTCBB:SFES) has sold 5 million shares of its common stock at $1 a share to 20 private investors for $5 million in proceeds.

Shares issued pursuant to the stock purchase agreement are restricted securities, and no registration rights have been granted.

Jeffrey Spragens, SafeStitch’s president and CEO. said that “this infusion of capital comes just as we are launching commercial sales of our AMID Stapler.

Dr. Stewart Davis, the company’s Chief Operating Officer, added that the funds “will also support final preparations and device production for ‘first-in-human’ clinical trials of our endoscopic gastroplasty kit, which we expect will begin later this year.”

Investors purchasing shares pwere Frost Gamma Investments Trust, an entity controlled by Dr. Phillip Frost, the largest beneficial owner of the Company’s common stock, Hsu Gamma Investments, L.P., an entity controlled by Dr. Jane Hsiao, the Company’s Chairman of the Board and Grandtime Associates Limited, a Taiwan-based investment company.

SoloHealth awarded $1.2M N.I.H. grant to advance Eyesite kiosks

Thursday, June 17th, 2010

SoloHealthATLANTA – SoloHealth, a technology company that develops and deploys interactive health screening kiosks across the US, has been awarded a $1.2M grant by the National Institute of Health (NIH) through its Small Business Innovation Research (SBIR) program.

We reported in May that the company had closed on half of a new $1 million round of financing. The company presented at the Southeast Venture Conference 2010.

The grant is to advance SoloHealth’s initial product, EyeSite, a vision screening kiosk, into a more comprehensive self-service health and wellness station. The new product will address highly problematic areas such as hypertension, obesity, eye health and vision, nutrition and diabetes.

Grant to bring kiosks to underserved markets

“With the recent health care legislation, 30 million previously uninsured Americans are about to become health care consumers, however, there isn’t a corresponding increase in medical providers to handle this surge – SoloHealth’s Health and Wellness kiosks will help close this gap, giving millions of Americans free and often, their first access to health care treatment and doctor/patient interaction,” said Bart Foster, CEO of SoloHealth.

The grant, which is funded by the National Center on Minority Health and Health Disparities, will aid SoloHealth in bringing free medical screening technology, education and wellness programs to a wider audience, including traditionally underserved communities.

SoloHealth’s Health and Wellness kiosks represent a new approach in publicly available, self-service health-screening. The kiosks are data-centric and use a combination of interactive health screening software and self-reported health information to produce individualized reports for consumers.

The customized reports also provide information on prevention, coupons for relevant products and services as well as doctor referrals to drive consumers to follow-up care and treatment.

The health kiosk operates in both English and Spanish, and has an analytics engine that is able to communicate to specific demographic and ethnicity.

SoloHealth’s EyeSite kiosk, which provides free vision screening, is already deployed in high-traffic retail locations like Kroger and Schnucks in seven markets including Atlanta, Birmingham, Houston, St. Louis, Richmond, Madison, WI and Salt Lake City. Nearly 100 EyeSite kiosks are providing vision screening for more than 400,000 people to-date. Significantly, 25 percent of users reported never previously having had an eye exam.

The company plans to use the NIH funding to develop and broaden the deployment of the Health and Wellness kiosks and plans to partner with at least two national retailers later this year.

Previously on TechJournal South: SoloHealth lands $1M round

Florida-based AccuDial Pharma taps in $4.6M of $7M raise

Thursday, June 3rd, 2010

AccudialPALM BEACH GARDENS, FL – Accudial Pharmaceutical Inc. has closed on more than half of a $7 million offering, according to a regulatory filing. The company, which sells a dosing system for administering over-the-counter children’s medication, has secured $4.6 million of the raise, according to a filing with the U.S. Securities and Exchange Commission.

The company closed a $4 million private placement in March.

Founded in Canada early this year, the company sells its eight products through Walmart and plans to launch a group of pediatric medications in the U.S. in the fourth quarter.

CardioMEMS sensor reduced heart failure hospitalization rates

Thursday, June 3rd, 2010

CardiomemsATLANTA – A clinical trial of the CHAMPION wireless heart sensor developed by Atlanta’s CardioMEMS reduced subsequent heart failure hospitalizations by 30 percent at six months and reached a 38 percent reduction a year over the entire trial period.

“Pulmonary artery pressure monitoring using the CardioMEMS CHAMPION pressure monitoring system represents our first meaningful improvement for the management of heart failure in nearly a decade,” said Dr. William Abraham, director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center.

The CHAMPION wireless HF sensor is an innovative miniature device that is implanted into the patient’s pulmonary artery using a simple, catheter-based procedure. The pulmonary artery pressure is then measured and displayed using the CardioMEMS proprietary electronic monitoring system.

Results from the trial were presented this week at the European Society of Cardiology Heart Failure Congress 2010 in Berlin, Germany.

We reported that the company raised a $37.9 million round of venture funding earlier this month. The results from this trial suggest why investors are bullish on the company.

Following the procedure, patients perform wireless measurements of their pulmonary artery pressure from home. The pressure data is immediately transmitted to a secure database and is available for review by the patient’s physician or nurse on the CardioMEMS CHAMPION website.