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NxStage Medical jumps on Baxter’s exit from the home hemodialysis market
Share prices for NxStage Medical (NSDQ:NXTM) jumped this week after Baxter (NYSE:BAX) CEO Joe Almeida said the company is pulling the plug on its Vivia home hemodialysis device.
Almeida, speaking at the Goldman Sachs investor conference June 7, said he evaluated the home dialysis market after he took over the corner office in October 2015.
“That is a very high hurdle, technologically speaking, because it’s a very difficult thing to achieve on an assisted basis,” Almeida said.
In evaluating the market, Almeida said he looked at 2 companies in the home dialysis arena: San Jose, Calif.-based Outset Medical...
Source: Mass Device - June 9, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Dialysis Wall Street Beat Baxter International NxStage Medical Inc. Source Type: news
Laminate Medical Technologies raises $8m in Series B
Israeli med device startup Laminate Medical Technologies has raised $8 million Series B financing round to support its VasQ blood vessel support device.
The company’s VasQ device is designed to aid kidney failure patients in need of dialysis by providing external support to reduce fistula failure.
The VasQ regulates flow by “constraining and shaping optimal geometrical parameters of the fistula,” the company said, and “reinforces and shields the vulnerable perianastomotic vein against high pressure, wall tension and flow levels.
The company has won CE Mark approval in the European Union for its VasQ dev...
Source: Mass Device - February 8, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Vascular Laminate Medical Technologies Source Type: news
Avenu Medical raises $13m
Vascular access system maker Avenu Medical has raised $13.1 million in a new round of equity financing, according to an SEC filing posted this week.
The company has not yet stated how it plans to spend funds raised in the round or when it plans to close the round.
Money in the round came from 77 unnamed sources, with the first sale officially dated today, according to the SEC filing. The company is looking for an additional $3 million, bringing the total raised to $16.1 million, before closing the round.
Last June, Avenu Medical said it won CE Mark approval in the European Union for its Ellipsys vascular access image-gui...
Source: Mass Device - February 15, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Catheters Vascular Avenu Medical Source Type: news
Mallory Sonalert Audible Medical Alarms meet IEC60601-1-8 standards.
Available in speaker MSS and SBS and piezoelectric SBT transducer types, Mallory Sonalert Audible Medical Alarms are used for hospital beds, drug dispensers, defibrillators, dialysis, MRIs, surgery equipment and incubators. Suitable for handheld devices, MSS and SBS provide 85dBa to 95dBa at 10cm loudness. Offering ultra-low current, SBT piezo series deliver 95dBa to 105dBa at 10cm loudness. Units are lightweight in range 6 g to 16 g and are RoHS compliant.This story is related to the following:Health, Medical,& Dental Supplies and EquipmentSearch for suppliers of:Medical Alarms
Source: Industrial Newsroom - Health, Medical and Dental Supplies - February 23, 2017 Category: Medical Equipment Source Type: news
AV Medical wins expanded FDA 510(k) for Chameleon PTA balloon cath
AV Medical Technologies said today it won expanded FDA 510(k) clearance for its Chameleon PTA balloon catheter designed for the infusion of diagnostic or therapeutic fluids.
The Chameleon is designed to allow operators to inject diagnostic or therapeutic fluids through the catheter during procedures, whether the balloon is inflated or deflated and while maintaining wire position, the Israel-based company said.
“The Chameleon balloon offers advantages for experienced operators as well as those training in dialysis access procedures. We appreciate the efficiency that it provides to these cases as well as the peace of m...
Source: Mass Device - February 27, 2017 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Catheters Food & Drug Administration (FDA) Regulatory/Compliance AV Medical Source Type: news
Merit Medical backs Bluegrass Vascular ’ s Surfacer ‘ inside-out ’ catheter
Bluegrass Vascular Technologies said today that it entered a “strategic relationship” with Merit Medical (NSDQ:MMSI) for its Surfacer “inside-out” catheter that includes an equity stake and a distribution agreement.
The Surfacer device is designed to provide access to the jugular vein to restore central venous access in hemodialysis patients with blocked neck veins; it won CE Mark approval in the European Union last August. The catheter is threaded through the femoral vein up to and into blockage in the jugular, which acts as a stabilizer. The head of the catheter is then aligned via fluoroscop...
Source: Mass Device - March 6, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Distribution Funding Roundup Vascular Wall Street Beat Bluegrass Vascular Technologies Merit Medical Systems Inc. Source Type: news
Medical Technology Venture Partners raises $20m toward $50m fund
Medical Technology Venture Partners reported raising $20 million for its maiden $50 million fund.
The San Francisco-based VC shop said in a regulatory filing that it raised the cash from 20 unnamed investors.
The fund is managed by Radu Cautis, according to a March 24 regulatory filing, whose LinkedPage lists him as an angel investor and former Gambro Renal employee (Baxter (NYSE:BAX) paid $4 billion for the Swedish dialysis giant in September 2013).
Cautis has a Twitter feed but has never used it for a public Tweet. A link on his Twitter page to raducautis.com lists Cautis as “[i]nvesting in and advising to start...
Source: Mass Device - April 3, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Funding Roundup Wall Street Beat Medical Technology Venture Partners Venture Capital/Private Equity Source Type: news
Outset Medical raises $76.5m Series C to support Tablo all-in-1 hemodialysis system
Outset Medical said today it raised $76.5 million in a Series C equity funding round to support its Tablo hemodialysis system.
The Tablo system is an all-in-one dialysis machine which handles both water purification and dialysate production and is designed to be used in a variety of settings, CEO Leslie Trigg told MassDevice.com.
The system is equipped with a touch screen interface and designed to be used by even the most basic user, Trigg said, something that sets it apart from other hemodialysis systems on the market.
“We designed it so that it’s acceptable for the average patient user to set up and manage their...
Source: Mass Device - May 3, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Business/Financial News Outset Medical Source Type: news
Fresenius Medical targets $27B in sales by 2020
Fresenius Medical Care (ETR:FRE) said it will look to grow its revenue to $26.9 billion (EU €24 billion) by 2020, as well as the launch of a global efficiency program looking to reduce spending.
The company made the announcement during its capital markets day in Frankfort this week.
Fresenius said that the goal of $26.9 billion represents an annual average growth rate of approximately 10%, during which the company hopes it will see a high single-digit percent increase in its net income.
The company said that it was driving towards the goals by developing its core business, and said it plans to continue growth of its ca...
Source: Mass Device - June 13, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Fresenius Medical Care Source Type: news
Outset Medical raises $4m
Outset Medical has raised $4.3 million in a new round of mixed financing, according to an SEC filing posted this week.
The San Jose, Calif.-based company develops and produces the Tablo hemodialysis system, an all-in-1 dialysis machine designed to handle water purification and dialysate production and be used in a variety of different settings.
Money in the round came from a single investor, with the 1st sale recorded on June 30, according to the filing. Sales in the round included debt, options and securities from exercisable options.
Outset Medical has not yet stated how it plans to use funds raised in the round.
The fun...
Source: Mass Device - July 5, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Outset Medical Source Type: news
Exthera Medical wins FDA EAP designation for Seraph 100 blood filter
Exthera Medical said today that the FDA granted its Seraph 100 blood filter an expedited access pathway designation.
The approval comes with an initial indication for use “as an adjunctive treatment for bacteremia in addition to antibiotics for patients receiving hemodialysis when the source of the infection is heparin- or heparin sulfate-binding bacteria, including antibiotic resistant bacteria MRSA, VRE, ESBL, CRE and MRSE,” the company said.
“We submitted our EAP application in early June. FDA responded by requesting additional information and clarifications, and Seraph was granted EAP designation with...
Source: Mass Device - August 30, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Food & Drug Administration (FDA) Regulatory/Compliance ExThera Medical Source Type: news
TVA Medical touts meta-analysis of everlinQ endoAVF treatments
TVA Medical today released data from a meta-analysis study of its everlinQ endovascular arteriovenous fistula system designed for hemodialysis access, touting a high procedure success rate and a high rate of fistula maturation.
Results from the 236-patient trial were presented at the Leipzig Interventional Course 2018, the Austin, Texas-based company said.
Data in the meta-analysis came from four clinical studies and 79 commercial cases, and indicated a 96.8% and 97.8% procedure success rate in clinical studies and real-world cases, respectively, as well as an acceptable safety profile.
The results also indicated 88% fistu...
Source: Mass Device - February 2, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular TVA Medical Source Type: news
Current Practice and Outcomes of Peritoneal Dialysis in the Nippon Medical School Musashi Kosugi Hospital.
CONCLUSION: The findings of this study revealed that assessment of the nutritional status of the patient and prevention of peritonitis are important for continuation of PD. PD is a safe treatment option that can maintain the quality of life in elderly patients. In a rapidly aging society, the need for PD-based medical care is expected to increase.
PMID: 29731493 [PubMed - in process]
Source: Journal of Nippon Medical School - May 8, 2018 Category: Universities & Medical Training Authors: Sumi Y, Sakai Y, Mugishima K, Suzuki A, Otsuka Y, Otsuka T, Tsuruoka S Tags: J Nippon Med Sch Source Type: research
FDA grants de novo clearance to Avenu Medical for Ellipsys vascular access system
Vascular access system maker Avenu Medical said today it won FDA de novo clearance for its Ellipsys vascular access system designed for use with end-stage renal disease patients who require hemodialysis.
The San Juan Capistrano, Calif.-based company touted that its Ellipsys EndoAVF technology acts as an alternative to traditional AV fistula creation. The system, which can be used under local or regional anesthesia, uses an ultrasound-guided catheter that delivers a small amount of thermal energy to fuse a permanent anastomosis between the vein and artery to create an AVF.
“Using the Ellipsys vascular access system ...
Source: Mass Device - June 27, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Vascular Avenu Medical Source Type: news
BD closes TVA Medical buy
Becton Dickinson (NYSE:BDX) wasted no time in closing the cash buyout of TVA Medical, which just a few weeks ago landed FDA clearance for its EverlinQ EndoAVF hemodialysis device, for an undisclosed amount.
Austin, Texas-based TVA won de novo clearance June 22 for the EverlinQ EndoAVF device, which uses a pair of magnetic catheters and radiofrequency energy to create an arteriovenous fistula for hemodialysis access without open surgery. BD said today that it plans to change the system’s name to WavelinQ EndoAVF as it integrates TVA into its peripheral intervention business.
“The FDA’s authorization a...
Source: Mass Device - July 9, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Dialysis Mergers & Acquisitions bectondickinson TVA Medical Source Type: news
