U.S. Food and Drug Administration has granted PhysioSonics' Presto 1000 Flow Monitor system 510k clearance for cranial blood flow monitoring. In addition, the company has completed of Series B add-on debt financing, closing with $1.05 million.

The Presto 1000 Flow Monitor is designed to allow any clinician to perform mid cerebral cranial blood flow monitoring, freeing institutions to more efficiently deploy sonographers who are required less often for the system. It is also designed to replace periodic measurement with continuous monitoring.

"The Presto 1000 Flow Monitor will help with ICU and surgical patients by detecting abnormal changes in cerebral blood flow and alerting the attending nurse, bringing further institutional resources to diagnose the cause. These flow anomalies may be indicators of severe conditions such as vasospasm from aneurysm ruptures or head trauma, disturbances with brain auto-regulation, or MCA blood clots," says Brad Harlow, CEO of PhysioSonics.

PhysioSonics uses its proprietary "Flash" Doppler for the monitoring functions. The addition of Flash, with the transducers attached to headset, assists in locating and maintaining the flow of information from mid cerebral arteries.

The company has 33 U.S. and foreign patents covering its technology. It has been the recipient of DARPA and NIH funding to use PhysioSonics technology to study head trauma, traumatic brain injury and bi-lateral flow monitoring.

The rise of biologic therapies will power growth in the prefilled syringes market – but only if manufacturers can solve current product problems, says a new report from healthcare industry experts GBI Research.

As explained in the business intelligence firm’s latest release, the development of injectable biologic therapies is a major factor for the future prospects of prefilled syringes, as many peptides contained in oral formulations are broken down too quickly in the stomach, compromising their effectiveness.

Currently, many biologic therapies are incompatible with the silicone used in glass syringes, necessitating a move to plastic variations and the development of new polymers and coatings that minimize reactions between the syringe material and the drug that cause contamination.

Glass has been the primary material in syringe manufacturing for decades, but is slowly being replaced as the advantages of polymer-based alternatives become apparent. Other than the possibility of product contamination, glass syringes are more fragile and are prone to flaking, but existing plastic versions are not without their own faults.

Cyclo-olefin polymers and co-polymers are the most commonly used plastic syringe variants in the market today, with several companies offering prefilled syringes in this form. However, while they are more durable and less likely to feature manufacturing defects than their glass counterparts, they are also more expensive to produce and are economically unsuitable for low price drugs.

Polypropylene syringes have been around since the 1990s, and although cheaper than the aforementioned plastics, it is a less transparent material and more difficult to sterilize.

GBI Research’s new report also predicts that the prefilled syringe market will be driven by the growth of home use and auto-injection devices that use a button-push mechanism – an innovative response to the common fear of needles. 
 

The equipment finance sector’s overall new business volume for November is up 3% compared to the same period in 2011, according to the Equipment Leasing and Finance Association’s latest Monthly Leasing and Finance Index.

The index also shows that new business volume is down 16% from last month; however, the year-to-date cumulative new business volume increased 15%.

Receivables over 30 days increased for the first time in six months to 2%, up from 1.7% in October, and they were unchanged when compared to the same period in 2011. Charge-offs were up from the previous month at 0.5%, and down by 28.6% compared to the same period last year.

Credit approvals totaled 77% in November, down from 79.5% in October. Forty-six percent of participating organizations reported submitting more transactions for approval during November, down from 66% the previous month.

Finally, total headcount for equipment finance companies was down 1% from the previous month, and declined 2% year over year.

Separately, the Equipment Leasing & Finance Foundation's Monthly Confidence Index (MCI-EFI) for December is 48.5, a decrease from the November index of 49.9, reflecting industry participants’ concerns regarding the impact of fiscal issues on capital expenditures, despite an overall sense of optimism in the equipment finance industry. 
 

Invacare Corp. (IVC) has reached an agreement on the terms of a consent decree of injunction with the United States Food and Drug Administration (FDA). The consent decree, which is subject to the approval of the United States District Court for the Northern District of Ohio, relates to previously announced inspectional observations at the Company's corporate facility and its Taylor Street wheelchair manufacturing facility, both located in Elyria, OH. The decree limits production and certain design activities at the two Elyria facilities until they are inspected and certified to be in compliance with FDA regulations by an independent third-party expert, and the FDA has notified the Company that it appears to be in compliance with applicable requirements. All other worldwide manufacturing facilities within the company remain in full operation.

``The Company is pleased to have reached an agreement with the FDA and believes it represents an important step forward for Invacare," says Gerry Blouch, Invacare president and chief executive officer. ``The terms of the decree contain important exceptions that will allow Invacare to continue to provide medically necessary products for the consumers who need them, as well as ongoing replacement, service and repair of products already in use. Throughout this process, the Company will try, as much as possible, to minimize the impact on its associates, customers, and the people who rely on Invacare products to make life's experiences possible."

TERMS OF THE DECREE
Subject to the approval of the Court, the terms of the decree, a copy of which will be disclosed by Invacare in a filing with the Securities and Exchange Commission (“SEC”), include, but are not limited to the following:

The injunction limits Invacare's manufacture and distribution of custom power and manual wheelchairs, wheelchair components and wheelchair subassemblies at or from its Taylor Street manufacturing facility. The decree also temporarily limits design activities related to wheelchairs and power beds that take place at the impacted Elyria facilities.

The Company may continue to fulfill orders and written quotes that are already in Invacare's order fulfillment system at the time the U.S. District Court enters the decree, as long as the provider completes a form certifying that he or she is aware of the decree and would still like for Invacare to fulfill the order.

Invacare may manufacture and distribute a patient's replacement chair and/or seating system when a patient requests the same or newer version of his/her existing product, and the clinician submits a verification of medical necessity form that acknowledges the existence of the decree.

The Company may manufacture and distribute power wheelchairs or seating systems from the Taylor Street facility, if a clinical evaluation determines that those products are medically necessary for a particular patient's condition which cannot be adequately addressed by another manufacturer's product, and the clinician and the patient's physician complete and submit a verification of medical necessity form.

Other exemptions exist to allow for ongoing service, repair and warranty replacement of products already in use as long as the provider completes a form certifying that he or she is aware of the decree and that parts and components they receive will be used solely for the service or repair of Invacare wheelchairs already in use.

PROCESS / NEXT STEPS
In order to resume full operations at the impacted Elyria sites, the Company must successfully complete a third-party expert audit that will be followed by an FDA inspection. The expert audit will review Invacare's compliance with the FDA's quality system regulations. The audit is divided into three separate reports, which would enable the Company to resume certain activities after written FDA approval of each of the first two reports while the Company continues to bring the remaining aspects of its quality systems into compliance. This certification audit process includes:

First, the third-party expert will inspect the qualification and validation procedures and documentation for equipment and processes at the Taylor Street manufacturing facility. Once the FDA has reviewed the report and notified the Company that those procedures appear to be in compliance, which may or may not require an FDA inspection, the Company will be permitted to resume the manufacturing of components and parts in its Taylor Street facility for the further manufacture of devices produced by other Invacare facilities.

Second, the third-party expert will review the Company's design control systems at the corporate and Taylor Street manufacturing facilities. Once the FDA has reviewed the report and notified the Company that the design control systems appear to be in compliance, which may or may not require an FDA inspection, the Company will be able to resume design activities of wheelchairs and power beds at the impacted Elyria facilities.

The final inspection by the third-party expert will be a comprehensive review of the Company's compliance with the FDA's quality system regulations at the impacted Elyria facilities. This audit will be followed by an FDA inspection. After receipt of a written notification from the FDA that it appears to be in compliance, the Company may resume full operations at the corporate and Taylor Street manufacturing facilities.

Blouch continued, ``As the industry leader in the design, manufacture and distribution of innovative home and long-term care medical products, Invacare is committed to full compliance with FDA regulations. The Company has made significant progress on the remediation of its quality systems. In fact, the Company recently began the first two third-party expert audits. Over the past year, the Company has added quality and regulatory personnel with medical device experience to its quality and regulatory affairs departments. In addition, the Company has engaged outside experts with proven quality systems and regulatory experience in the medical device industry to accelerate its quality system remediation. The Company has had a constructive dialogue with the FDA and it looks forward to fulfilling its obligations under the terms of the agreement in a timely manner. Invacare is confident that these improvements will make it an even stronger company."

When the consent decree becomes effective, the Company will closely monitor the level of production at the Taylor Street facility as it determines the impact of orders related to medical necessity and the customers who elect to fulfill existing orders and written quotes. While the Company expects a reduction in the operations workforce at the Taylor Street facility, the timing is uncertain. For these reasons and given the uncertainty of when full production will resume, the Company is unable to provide financial guidance. However, for information purposes, the Company estimates that the products manufactured at the Taylor Street facility represented approximately $172 million in net sales for the full year 2011 in the North America/HME segment and approximately $114 million in net sales for the nine months ended September 30, 2012 in the North America/HME segment.