ALPHARETTA, Ga., March 3, 2015 (GLOBE NEWSWIRE) -- SANUWAVE Health, Inc. (OTCQB:SNWV), today reported financial results for the year ended December 31, 2014 and provided a business update. The Company will host a conference call tomorrow, March 4, 2015, at 10:00 a.m. Eastern Time.
Highlights of 2014 and recent weeks:
- Completed a private placement for $9.3 million in gross proceeds from the sale of the Company’s stock and warrants which closed in March 2014.
- Enrolled the 130th patient in the Phase III supplemental clinical trial using dermaPACE® for treating diabetic foot ulcers in November 2014, which represents the number of patients the Company must enroll for the second interim analysis by the independent Data Monitoring Committee (DMC). The Company suspended further enrollment in the study until the DMC provides their recommendations to the Company which is expected in April 2015.
- Received the following three U.S patents:
- U.S. patent entitled “Medical Treatment System Including an Ancillary Medical Treatment Apparatus with an Associated Data Storage Medium” (patent number 8,961,441) related to medical treatment systems that include electronic devices and auxiliary treatment interfaces with enhanced controls for identification and authentication of proper treatment components, and for providing specific treatment parameters based on the medical condition.
- U.S. patent entitled “Use of Pressure Waves for Stimulation, Proliferation, Differentiation and Post-Implantation Viability of Stem Cells” (patent number 8,728,809) related to the use of shock waves for the stimulation and proliferation, inside the body, of donor stem cells and their usage for implantation or for laboratory proliferation to create either autologous or allogeneic transplant cells.
- U.S. patent entitled “Methods and Devices for Cleaning and Sterilization with Shock Waves” (patent number 8,685,317) related to the use of shock waves to clean and sterilize fluids in containers and/or pipes.
- U.S. patent entitled “Medical Treatment System Including an Ancillary Medical Treatment Apparatus with an Associated Data Storage Medium” (patent number 8,961,441) related to medical treatment systems that include electronic devices and auxiliary treatment interfaces with enhanced controls for identification and authentication of proper treatment components, and for providing specific treatment parameters based on the medical condition.
- Signed a strategic agreement with Premier Shockwave to manage the Company’s OssaTron® devices in the U.S for the treatment of heel pain and tennis elbow.
- Became a member of the Center for Biofilm Engineering at Montana State University, the leading university in biofilm research, and attended the Anti-Biofilm Technologies: Pathways to Product Development conference held in February 2015.
- Continued testing of the Company’s patented shock wave technology in collaboration with the following:
- Blood sterilization at the University of Georgia.
- Biofilm disruption at Montana State University.
- Stem cell proliferation at Harvard University.
- Established an off-site water cleaning small scale model testing facility and began preliminary testing for the cleaning of dirty industrial type waters.
- Signed a memorandum of understanding with Dasman Diabetes Institute and Kuwait Life Sciences Company (KLSC) to introduce the dermaPACE device as a treatment for diabetic foot ulcers in the Gulf Cooperation Council (GCC) region.
“We enrolled up to the second independent review point of 130 patients in our Phase III supplemental clinical trial using dermaPACE for treating diabetic foot ulcers, fortified our intellectual property portfolio with the issuance of three key U.S. patents, as well as continued some of the initiatives using our patented PACE technology in other medical and non-medical areas in collaboration with some leading research universities,” stated Kevin A. Richardson, II, Chairman of the board of SANUWAVE. “We continue to pursue non-dilutive financing opportunities through license and distribution arrangements for our patented CE Marked technology and I look forward to updating shareholders in these areas in the future.”
2014 Financial Results
Year Ended December 31, 2014 Financial Results
Revenues for the year ended December 31, 2014 were $847,367, compared to $800,029 for the prior year, an increase of $47,338, or 6%. The increase in revenues for 2014 was due to higher sales of orthoPACE® devices in 2014 in Asia/Pacific, as compared to the prior year, as well as higher sales of refurbished applicators in Europe.
Operating expenses for the year ended December 31, 2014 were $6,590,882, compared to $6,586,199 for the prior year, an increase of $4,683. Research and development expenses increased by $704,145, primarily as a result of the dermaPACE clinical study starting the more costly patient enrollment and treatment phase in June 2013. This was offset by a decrease in general and administrative expenses of $694,173, primarily due to reduced stock based compensation expenses for employee stock options and consulting services in 2014.
Net loss for the year ended December 31, 2014 was $5,974,080, or ($0.12) per share, compared to a net loss of $11,299,721, or ($0.40) per share, for the prior year, a decrease in the net loss of $5,325,641, or 47%. The decrease in the net loss was primarily a result of the decrease in the net expense in other income (expense) of $5,968,231 for 2014, as compared to 2013, for the accounting for the Senior Secured Notes which were converted to equity in the third quarter of 2013.
On December 31, 2014, the Company had cash and cash equivalents of $3,547,071 compared with $182,315 as of December 31, 2013, an increase of $3,364,756. For the year ended December 31, 2014 and 2013, net cash used by operating activities was $6,678,369 and $3,924,204, respectively, an increase of $2,754,165, or 70%. The increase was primarily due to the increased research and development expenses in 2014, as compared to 2013, of $704,145 for expenses associated with the dermaPACE clinical trial and the reduction of accounts payable and accrued expenses in 2014 of $1,197,304. Net cash provided by financing activities for the year ended December 31, 2014 and 2013 was $10,071,149 and $4,035,122, respectively, which in 2014 primarily consisted of the net proceeds from the 2014 Private Placement of $8,562,500, the proceeds from sale of capital stock per the Subscription Agreement with a related party of $900,000, and the proceeds from the 18% Convertible Promissory Notes of $815,000. In 2013, net cash provided by financing activities primarily consisted of the net proceeds from the subscriptions payable for Senior Secured Notes of $1,570,000 and the net proceeds from the July 2013 public offering of $1,517,450.
Conference Call
The Company will also host a conference call on Wednesday, March 4, 2015, beginning at 10 a.m. Eastern Time to discuss the 2014 financial results, provide a business update and answer questions. Shareholders and other interested parties can participate in the conference call by dialing 877-407-9055 (U.S. and Canada) or 201-493-6743 (international).
A replay of the conference call will be available beginning two hours after its completion through March 18, 2015, by dialing 877-660-6853 (U.S. and Canada) or 201-612-7415 (international) and entering Conference ID 414704.
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s Premarket Approval (PMA) review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.
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