SNWV: More Insight Into Why dermaPACE Works (SNWV)

Brian Marckx, CFA

This morning SANUWAVE Health (SNWV) announced that additional data from a clinical trial comparing dermaPACE to hyperbaric oxygen therapy (HBOT) was published in the online edition of Diabetes Research and Clinical Practice. Data from the initial study titled, Treatment of Diabetic Foot Ulcers: A Comparative Study of Extracorporeal Shockwave Therapy and Hyperbaric Oxygen Therapy, revealed that dermaPACE was more effective than HBOT in healing diabetic foot ulcers (DFU). Data from this morning's announcement, from a study titled, Molecular Changes in Diabetic Foot Ulcers, provided insight into the reasons why dermaPACE is more effective.

Initial Study Results
As a refresher on the dermaPACE versus HBOT therapy trial: SANUWAVE had previously announced data from the initial study titled, Treatment of Diabetic Foot Ulcers: A Comparative Study of Extracorporeal Shockwave Therapy and Hyperbaric Oxygen Therapy. The Taiwan-based study included 77 patients with chronic, non-healing DFU of at least three months duration which were grade III or IV (i.e. late stage). The dermaPACE cohort (39 patients, 44 ulcers) received two 20-minute procedures each week for three weeks (6 procedures in total). The HBOT group (38 patients, 40 ulcers) received five 90-minute treatments each week, once daily for eight weeks (40 procedures in total). Both cohorts also received standard of care treatment. Blood flow perfusion exams and biopsy were done prior to treatment and again after conclusion of final treatment. Increased perfusion blood flow is generally considered to have a beneficial effect on healing. Patient follow-up was conducted at three and six weeks and then once every three months up to 18 months. A second course of treatment was offered to patients who responded to treatment but with less than complete healing after 4 6 weeks of treatment.

HBOT uses pressurized oxygen to aid in the healing process and involves the use of an oxygen chamber. HBOT therapy is used and reimbursed by Medicare for a variety of ailments including for DFU. HBOT not only requires multiple treatments making it less convenient than dermaPACE, it can also be very expensive, costing between $200 and $1,000 (cost dependent on the treatment venue) per 90 minute session.

Results…
Data from the study showed;

• Complete healing in 57% of the DFUs in the dermaPACE group compared to just 25% in the HBOT group (statistically significant, p=0.003)
  >One course of treatment resulted in 24 ulcers completely healed in the dermaPACE group compared to just 10 ulcers completely healed with HBOT
  >For those patients receiving a second course of treatment (31 ulcers), 50% (7 of 14) of dermaPACE treated ulcers completely healed compared to only 6% (1 of 17) treated with HBOT

• 60% of HBOT treated ulcers were unchanged in size and depth, versus just 11% of those treated with dermaPACE (statistically significant, p=0.001)
• Perfusion blood flow increased by 27% in the dermaPACE group (statistically significant, p<0.001) while staying the same in the HBOT group
• dermaPACE treatment required 97% less treatment time than HBOT

	dermaPACE	HBOT	p-value
Complete healing (all courses)	57%	25%	0.003
Ulcers unchanged in size and depth	11%	60%	0.001
Perfusion blood flow increase	27%	0%	0.001

New Data
This morning's data comes from the same clinical trial detailed above but provides more insight into how dermaPACE works. This study found a statistically significant increase in molecular changes in the dermaPACE cohort compared to the patients in the HBOT group.

For a free copy of the SNWV research report, please email scr@zacks.com with SNWV as the subject.

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