Guided Therapeutics Successfully Completes Canadian Standard Association Requirements for LuViva® Advanced Cervical Scan
Edition 3 CE Mark third-party product safety testing complete
Norcross, GA, January 7, 2013 Guided Therapeutics, Inc., (OTCBB: GTHP), today announced that it has successfully completed third-party testing of the LuViva® Advanced Cervical Scan. This puts LuViva in compliance with Canadian Standards Association (CSA®) requirements which, while not required for marketing in Canada, are preferred by certain larger medical institutions. It also puts the company one step closer to applying the Edition 3 CE Mark to LuViva.
"The completion of CSA standards certification is an independent validation of the safety and integrity of LuViva’s design,” said Mark L. Faupel, CEO and President of Guided Therapeutics, Inc. “In addition to further opening up the Canadian market, the certification documentation can be used as a basis for obtaining regulatory approval and subsequent sales in certain Latin American and Asian countries.”
The testing for the certification was conducted in parallel with CE Mark testing by SGS U.S. Testing Company, Inc. - a Nationally Recognized Test Lab. LuViva will carry the SGS USTC Mark for both Canada and the U.S. With all third-party testing complete, the remaining steps for the Edition 3 CE Mark are to complete final mechanical tests and submit for review final documentation, a process which is expected to take a few weeks. Guided Therapeutics plans to then immediately apply the Edition 3 CE Mark to the LuViva in order to support its international product launch in the first quarter of 2013.
LuViva currently has marketing approval from Health Canada and received its first CE Mark, an ISO 60601 Edition 2 Notification, in July. Guided Therapeutics was awarded ISO 13485 certification in January 2011. Additionally, LuViva has been under U.S. Food and Drug Administration Premarket review since September 23, 2010. After meetings with the FDA, the Company filed an amended PMA application with the agency in November 2012.
About LuViva® Advanced Cervical Scan
LuViva is a technologically advanced diagnostic device that scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue. Spectroscopy identifies chemical and structural indicators of precancer that may be below the surface of the cervix or misdiagnosed as benign. This technique is called biophotonics. Unlike Pap, HPV tests or biopsies, LuViva does not require laboratory analysis or a tissue sample, and is designed to provide results immediately, which eliminates costly, painful and unnecessary testing. LuViva is designed for use with women who have undergone initial screening and are called back for follow up with a colposcopy examination, which in many cases, involves taking a biopsy of the cervix. The device is used in conjunction with the LuViva® Cervical Guide single-use patient interface and calibration disposable.
Innovative Bio-Hazardous Waste Management Solution now Offered in Canada
CAN-med Healthcare has been selected by Bertin Technologies as the Canadian distributor of leading Sterilwave technology
Halifax, Nova Scotia, December 18, 2012 CAN-med Healthcare, a Canadian value-added distributor of medical/surgical, health imaging, dental and mobility products, has been named by Bertin Technologies, a developer and supplier of highly technological equipment, as the exclusive reseller of the Sterilwave 440 waste management system.
The Sterilwave is a revolutionary machine which sterilizes bio-hazardous waste in an environmentally safe and conscious manner. The result is ordinary solid waste that no longer poses a threat to humans or the environment. This fully automated system provides a greatly reduced risk of exposure to bio-hazardous material for hospital staff as it requires no intermediate handling. The breakdown of materials is environmentally friendly with no liquid effluent or hazardous emission.
This product was designed for placement in hospitals and clinics where bio-hazardous waste requires treatment. It reduces costs within the medical facility by eliminating the need for special transport of dangerous materials. The by-product of this process is harmless solid waste which can be disposed of by traditional methods. The Sterilwave reduces waste volume and weight for easy and cost effective removal.
“We are excited to bring this innovative product and all of its environmental benefits to the Canadian healthcare market” said Jim Ritcey, National Director of Sales & Marketing, Medical/Surgical Division, CAN-med Healthcare. “We believe this technology will change the landscape of bio-hazardous waste management within hospitals and increase safety, efficiency and environmental awareness.”
“The partnership between Bertin and CAN-med Healthcare is a perfect fit,” said Boguslaw Lorecki, Manager, Bertin Technologies. “Both companies are pushing the boundaries of innovative healthcare products offered. We believe CAN-med Healthcare, with their strong distribution channel, will ensure Sterilwave is a success in Canada and open the door for a new type of biomedical waste management.”
For more information on Bertin Technologies visit http://www.bertin.fr/en/index.aspx. To order, and for more information on CAN-med Healthcare, visit www.canmedhealthcare.com or contact 1 (800) 565-7553.
Canadian Reseller of Medical Products Signs Exclusive Agreement with International Manufacturer of Medical Technologies
CAN-med Healthcare to sell leading products from designer and manufacturer, Hill-Rom, in Nova Scotia, New Brunswick and Prince Edward Island
Halifax, Nova Scotia, October 18, 2012 CAN-med Healthcare, a Canadian value-added distributor of medical/surgical, health imaging, dental and mobility products, and Hill-Rom, a leading worldwide manufacturer and provider of medical technologies, are pleased to announce that they have entered into an agreement making CAN-med Healthcare the exclusive reseller of Hill-Rom’s innovative products in Nova Scotia, New Brunswick and Prince Edward Island.
Hill-Rom is a leading manufacturer of medical beds, stretchers, sleep surfaces, patient lifts and patient room furniture designed specifically for common patient needs. Hill-Rom’s hospital beds can also be customized for unique conditions.
Both organizations are dedicated to offering customers the highest quality solutions for their individual needs, to ensure patient comfort and safety. This commitment to well-being makes the new relationship between manufacturer and distributor a perfect fit to serve hospitals and long-term care homes, further enhancing the level of care available to patients in these facilities.
“We are proud to offer products from an organization equally dedicated to putting the customer’s needs and well-being first and foremost” said Stephen McDonald, Vice President & General Manager, CAN-med Healthcare. “Hill-Rom’s innovative products are a staple of the healthcare industry in the Maritime Provinces and we are happy to ensure patients here have the opportunity to access the best options for comfort and safety on the market”
“Hill-Rom is excited and looking forward to our new partnership with CAN-med Healthcare in Eastern Canada” said Wayne Flynn, Vice President & General Manager, Hill-Rom Canada. “CAN-med Healthcare’s reputation, corporate strength, and strong sales and marketing presence will benefit not only our efforts, but the patients and caregivers we both serve.”
For more information on Hill-Rom products visit www.hill-rom.com/canada/. To order, and for more information on CAN-med Healthcare, visit www.canmedhealthcare.com or contact 1 (800) 565-7553.
Client Feedback Leads to Educational Trade Show for Rehabilitation Professionals in Atlantic Canada
Harding Medical and MEDIchair Nova Scotia launch the first Atlantic Rehab and Education Conference
Halifax, Nova Scotia, August 1, 2012 Harding Medical, a home healthcare equipment and mobility product specialty store with three locations throughout Atlantic Canada, and MEDIchair Nova Scotia, a provider of home medical equipment, supplies and services to customers and clinics through retail stores located in Nova Scotia, are pleased to announce the first Atlantic Rehab and Education Conference, which is being held September 20-21, in Halifax, Nova Scotia.
In late 2011, both mobility organizations reached out to their partners and clients to determine what they could do to help enhance the level of support offered to rehab and mobility patients. The overwhelming response was increased education on the latest trends, technology and products in rehab and mobility. Harding Medical and MEDIchair Nova Scotia addressed this feedback by developing a conference, with the vision of bringing together product vendors and leading speakers in the industry to provide continuing education to occupational therapists, physiotherapists and other healthcare professionals working in rehabilitation, or a long-term care setting.
Planning has been underway since that time and both organizations are pleased to announce that the first Atlantic Rehab and Education Conference will take place at the Atlantica Hotel Halifax on September 20-21. Booth space for the product trade show is already sold out, with leading mobility vendors participating. The conference will feature 12 informational sessions, spanning two days and a keynote speaker to provide the ongoing education that clients requested.
“We are excited and proud to host this inaugural rehab and mobility conference,” said Blake Scott, General Manager, Home Medical Equipment, Harding Medical and MEDIchair Nova Scotia. “We anticipate the event to be a huge success because we created it in response to what our clients requested. It is our priority to put our clients first and meet their demands, so they can in turn offer the best care to their patients.”
Registration for the Atlantic Rehab and Education Conference is now open. To register, and for more information on the conference, please visit www.atlanticrec.ca or contact atlanticrec.ca.
CAN-med Healthcare Launches dermaPACE Device throughout Canada for Wound Healing
Halifax, Nova Scotia, February 24, 2012 CAN-med Healthcare, a division of IMP Group Limited,announces an exclusive distribution agreement to distribute SANUWAVE's dermaPACE® device to throughout Canada. Headquartered in Bedford, Nova Scotia, CAN-med Healthcare will initially promote dermaPACE to heal diabetic foot ulcers (DFUs). The dermaPACE regenerative medicine device is a safe, cost-effective, noninvasive and easily administered wound closure modality that uses pulsed acoustic pressure waves (shock waves) to stimulate biologic effects at the molecular, cellular and tissue levels to positively modulate microvascular and inflammatory processes, ultimately leading to wound healing.
dermaPACE recently completed a randomized, sham-controlled, double-blinded, 24-site Phase III clinical trial investigating dermaPACE to treat diabetic foot ulcers when combined with standard of care. dermaPACE patients received four, 20-minute procedures over two weeks, followed only by standard wound care regimens that included debridement, saline-moistened gauze dressing changes, and offloading as indicated.
In this rigorously designed study, which had a primary efficacy endpoint of 100% would reepithelialization and disallowed surgical closure, 48% of dermaPACE patients achieved ≥90% wound area reduction at 12 weeks, which was statistically significant compared with Sham-control. In addition, dermaPACE patients achieved, on average, a 49% reduction in wound area four weeks following the last active treatment, a result the literature reports as being predictive of complete wound closure at 12 weeks. Importantly, the recurrence rate at 24 weeks for dermaPACE-treated ulcers that completely closed at 12 weeks was only 4.5%.
For more information, contact Jim Ritcey at CAN-med Healthcare at (902) 233-4873.
I.M.P. Group Achieves Platinum Club Status As One Of Canada’s 50 Best Managed Companies
Halifax, Nova Scotia, February 16, 2010 I.M.P. Group International Inc. has achieved Platinum Club member status with Canada’s 50 Best Managed Companies program, one of the country’s most elite business designations.
Canada’s 50 Best Managed Companies is a national awards program recognizing Canadian companies that have implemented world-class business practices and created value in innovative ways. To become a Platinum Club member, companies must maintain their designation as one of Canada’s 50 Best Managed Companies for a minimum of six consecutive years subject to annual operational and financial review. The awards program is sponsored by Deloitte, CIBC Commercial Banking, National Post, and Queen’s School of Business.
“I want to congratulate I.M.P. Group on becoming a Platinum Club member. This designation exemplifies consistency, commitment and the ability to be flexible in a changing marketplace. In tougher economic times, great management shines, and these qualities are what makes I.M.P. Group such a great business success story and one of Canada’s 50 Best Managed Companies,” said John Hughes, Partner, Private Company Services Group with Deloitte.
“I am thrilled that the Company and our employees have achieved Platinum status,” says I.M.P. Group CEO, Stephen Plummer. “This validates the efforts everyone has made to focus on productivity, innovation, and satisfying our customers. We compete in a global marketplace and are focused on remaining industry leaders as we grow our core businesses.”
I.M.P. Group International Inc. is focused on global sustainable growth, with 3,700 experienced people delivering service, quality and value to customers across diverse sectors, such as aerospace, aviation, airline, healthcare, industrial marine, information technology, hospitality and property development.
CAN-med Healthcare to Distribute LuViva® Advanced Cervical Scan in Canada
Halifax, Nova Scotia, January 31, 2012 CAN-med Healthcare announces that it has signed a definitive agreement with Guided Therapeutics, Inc. for exclusive distribution rights in Canada for their LuViva® Advanced Cervical Scan.
The agreement is for three years and initial shipments are currently anticipated in the second quarter of 2012. A formal launch is expected to begin shortly thereafter. LuViva received Health Canada marketing approval in December 2011 under its former name, LightTouch.
“CAN-med is a leading and greatly respected healthcare company and we are pleased to have them as our partner in Canada,” said Mark L. Faupel, Ph.D., CEO and president of Guided Therapeutics, Inc. “CAN-med’s nation-wide reputation and commitment to women’s health, from mammography to gynecological imaging products, makes the company ideally suited to introduce LuViva to the Canadian market and grow market share.”
“Based on LuViva’s documented clinical evidence and our 35 years of experience delivering innovations to the Canadian healthcare market, we believe that LuViva will be well received, with an opportunity to positively impact the lives of women at risk for developing cervical cancer,” said Jim Ritcey, Director, Sales and Marketing, Medical/Surgical for CAN-med Healthcare. “Additionally, we believe that LuViva will bring a new level of efficiency and cost effectiveness to the healthcare system.” Stephen McDonald, CAN-med’s Vice President & General Manager adds “Guided Therapeutics and the LuViva product are a great match for us in bringing new products to the Canadian market. They fit the criteria we’re looking for by being clinically innovative with new technology, being willing to develop an exclusive working relationship, and delivering better clinical and patient outcomes.”
Each year in Canada, about 5.7 million women undergo Pap test screening for cervical cancer, with as many as 400,000 receiving an abnormal Pap result. These women are then scheduled for a follow-up exam, called a colposcopy, which typically includes a biopsy. The wait times for colposcopy examinations in Canada are typically between two to six months. LuViva is designed to reduce wait times and provide results immediately at the point of care.
About CAN-med Healthcare
CAN-med Healthcare, a division of IMP Group Limited, is a national, integrated healthcare distribution and service company with a portfolio of businesses providing products and technical service spanning four distinct segments of the healthcare market: Medical/Surgical; Diagnostic Imaging; Rehab/Mobility/Home Medical Equipment; and Dental products.
IMP Group Limited is focused on global sustainable growth with 3,700 experienced people delivering service, quality and value to customers across diverse sectors including aerospace, aviation, airline, healthcare, information technology, hospitality and property development.