Significant Promise of Targeted Hypertension Treatment Using PeriVascular Renal Denervation (PVRD™)

Newswise — KALAMAZOO, Mich., June 19, 2012 /PRNewswire/ -- Ablative Solutions, Inc. (ASI), a privately-held company headquartered in Kalamazoo, MI with offices in Menlo Park, CA announced today that it has completed a Series A Preferred Stock financing, totaling approximately $5.3 million (including the conversion of the bridge financing completed earlier this year), to fund its unique technology platform. The round was led by BioStar Ventures and the Michigan Accelerator Fund, and included participation by multiple angel investors. Honigman Miller Schwartz and Cohn LLP served as legal advisor to ASI for the transaction.

ASI is developing a significantly different approach to Renal Denervation, a new therapy that addresses hypertension and other diseases related to overactive sympathetic nerve activity. The sympathetic nerves that run along the renal artery play an essential role in controlling blood pressure but, when overactive, contribute to hypertension. Renal Denervation has been demonstrated to reduce blood pressure in patients who are not effectively treated by medical therapy. De-activating these nerves modulates the signaling process, and helps to reduce blood pressure. Unlike other approaches to Renal Denervation, which deliver destructive energy through the entire renal artery wall, ASI has developed a unique device that targets treatment directly to the nerves that encircle the renal artery, without damaging the artery wall — a solution that ASI calls PeriVascular Renal Denervation (PVRD™).

"Hypertension has an extraordinary impact on health, but it is a disease that is underappreciated. There is good reason for the excitement surrounding Renal Denervation – it produces a persistent, durable reduction in blood pressure with a minimally invasive procedure," observed Dr. Tim Fischell, CEO and CMO of ASI. "ASI seeks not only to simplify and streamline the denervation procedure, but, more importantly, to do so without damaging the vessel wall, by delivering the therapy directly to where the sympathetic nerves reside, just outside the blood vessel."

"We believe that ASI's simple, elegant approach will address the clinical need effectively," stated Dr. Vartan Ghazarossian, President and COO of ASI. "Our technology development is driven by the awareness that less is more — providing optimized ablation of the sympathetic nerve less invasively and with less equipment and a shorter procedure time." The Company projects that its clinical evaluations will begin in 2013.

ASI was founded by two proven medical device entrepreneurs, Tim Fischell, MD and David Fischell, PhD. With executive experience in both biopharmaceutical and medical device companies, Vartan Ghazarossian, PhD, is uniquely positioned to lead the development of ASI's novel device-chemistry-based therapy. Dr. Steven Almany of BioStar Ventures, a member of ASI's Board of Directors, commented: "The therapeutic potential of perivascular renal denervation is very attractive, and we are very pleased to invest in ASI's team as they develop their unique approach."

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities in this offering. There will not be any sale of these securities in any state or jurisdiction in which such offering, sale or solicitation would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Forward-Looking Statements

This press release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. Information in this press release, which is not historical, is forward-looking and involves a number of risks and uncertainties. Investors are cautioned not to put any undue reliance on any forward-looking statement. ASI's actual results may differ materially from ASI's historical results of operations and those discussed in the forward-looking statements for various reasons, including, but not limited to ASI's ability to carry out its business plan, successful development and commercial acceptance of its products, ability to fund development necessary for existing products and for the pursuit of new product opportunities, ability to hire required personnel, the risk of whether products result from development activities, protection of ASI's intellectual property portfolio, the risk associated with obtaining the necessary regulatory approvals, the ability to obtain foreign regulatory approvals for products and to establish marketing arrangements in countries where approval is obtained, and other potential factors.

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The number of children hospitalized for high blood pressure has increased dramatically over the past decade – almost doubling from 12,661 in 1997 to 24,602 in 2006.

After calculating discharge records from the Healthcare Cost and Utilization Project (HCUP) Kids’ Inpatient Database, researchers also discovered the rise in hypertension-related hospitalizations has led to a 50 percent increase in costs for inpatient care – reaching approximately $3.1 billion.

The study, published in the American Heart Association journal Hypertension, stemmed from the equally dramatic increase in hypertension being seen in adults in the U.S.

“Looking through the research, there’s definitely a lot of published reports looking at the frequency of hypertension in outpatient settings, but there’s not a lot of inpatient data, especially in pediatrics,” Dr. Cheryl Tran, a fellow in the Department of Pediatric Nephrology at the University of Michigan in Ann Arbor and the study’s lead author, told FoxNews.com.  “Numerous studies have examined the adult population, so given that trend in hypertension, we want to see how that translated over to the inpatient landscape.”

Along with discovering the increase in hospitalizations and economic costs, Tran and her team also found that the average length of stay for children with hypertension was twice as long as stays for children with other illnesses – typically lasting eight days compared to four.  The most common diagnoses for hospitalized children included pneumonia, acute appendicitis and asthma.

While the scientists only focused on discharge data, they could not account for the exact rise in hypertension among children.  However, they did speculate that obesity and nutrition played a key role in their findings.

“We hypothesized that the rise of hypertension may be in part to obesity,” Tran said.  “We looked at both primary diagnoses and secondary diagnoses, in order to account for everyone that might have been treated for this particular disorder.  When hypertension was the primary diagnosis, obesity was one of the top second most common diagnoses.”

If high blood pressure was only a secondary diagnosis, children often were first diagnosed with lupus, complications due to kidney transplants, pneumonia and acute proliferative glomerulonephritis – inflammation in the kidney that can cause hypertension.

With such staggering statistics, Tran advocated for preventative health education for parents.  Not only are the economic consequences high, she said, but children could suffer later in life if their hypertension is not addressed quickly.

“It’s important that the health care community and families are addressing healthy lifestyle habits,” Tran said. “That they’re working together to identify children with hypertension early on.  They need to be cognizant of their [children’s] growth percentiles and their blood pressures.  That’s the first step to preventing this condition.”

“It’s important because children with high blood pressure are at risk for high blood pressure in adulthood,” Tran added, “and the complications of that are large.”

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