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EnteroMedics Announces First vBloc Neurometabolic Therapy Implant at McGuire Veterans (17.05.2017)

EnteroMedics Inc , the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, announced that the McGuire Veterans Affairs Medical Center in Richmond, VA successfully completed its first implant of the Company's vBloc® Neurometabolic Therapy. The surgery was performed earlier this week by James Maher, MD.

"Obesity and its comorbidities must be addressed in order to live a healthier and fuller life," said Dr. Maher. "Providing the best medical options to combat morbid obesity to the men and women who have served our country is a top priority and with vBloc Therapy available at the Richmond VAMC, we are now able to provide a safe and effective alternative to invasive, anatomy-altering and restricting procedures. There are well over one million veterans with obesity and the Richmond VAMC is committed to helping those in our communities succeed in their fight against obesity."

The vBloc System works to control sensations of hunger using a pacemaker-like device that is implanted under the skin during a safe, minimally-invasive procedure that does not alter or remove any patient anatomy. The device can be adjusted to optimize patients' therapy needs and works to give the patient a sensation of fullness, empowering them to eat less, control their appetite, and lose weight. Studies have shown that vBloc Therapy produces meaningful weight loss in patients as well as meaningful improvements in related comorbidity factors, such as HbA1c, without the major lifestyle implications of traditional weight loss surgeries.

"One in ten Virginians is a veteran and the State has the fastest growing veterans' population in the Nation," said Dan Gladney, EnteroMedics President, Chief Executive Officer and Chairman of the Board. "With our first implant at the Richmond VAMC, we are making vBloc accessible to an even larger portion of the men and women who have served our country selflessly and are in need of solutions to address their obesity. Through our previously announced partnership with Academy Medical, eligible veterans are able to receive vBloc Therapy at little to no cost. We look forward to working with other VA medical centers and VA Choice facilities so they can offer this state-of-the art weight loss treatment."

vBloc Therapy is approved for use in helping with weight loss in people aged 18 years and older who are obese, with a BMI of 40 to 45 kg/m2, or a BMI of 35 to 39.9 kg/m2 with a related health condition such as Type 2 diabetes, high blood pressure, high cholesterol levels or obstructive sleep apnea who have had a poor response to trying to lose weight under supervision in the last 5 years.

About McGuire Veterans Affairs Medical Center
The McGuire Veterans Affairs Medical Center is home to the latest and most sophisticated medical equipment and facilities for health care delivery for our Nation's Heroes. Last year, the medical center served nearly 60,000 veterans and active duty service members with more than 700,000 visits. Over 80% of the medical center's research has a direct impact on patient care studies in the VA system and in the community. The medical center also provides outpatient services through the Fredericksburg, Emporia, and Charlottesville VA Community Based Outpatient Clinics.

About EnteroMedics Inc.
EnteroMedics is a medical device company focused on the development and commercialization of its neuroscience based technology to treat obesity and metabolic diseases. vBloc® Neurometabolic Therapy, delivered by a pacemaker-like device called the vBloc® System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. EnteroMedics' vBloc® System has received U.S. Food and Drug Administration approval and CE Mark.

Information about the vBloc® System and vBloc® Neurometabolic Therapy
You should not have an implanted vBloc® System if you have cirrhosis of the liver, high blood pressure in the veins of the liver, enlarged veins in your esophagus or a significant hiatal hernia of the stomach; if you need magnetic resonance imaging (MRI); if you have a permanently implanted, electrical medical device; or if you need a diathermy procedure using heat. The most common related adverse events that were experienced during clinical study of the vBloc System included pain, heartburn, nausea, difficulty swallowing, belching, wound redness or irritation, and constipation.

Talk with your doctor about the full risks and benefits of vBloc Therapy and vBloc System. For additional prescribing information, please visit www.enteromedics.com.

If you are interested in learning more about vBloc Neurometabolic Therapy, please visit www.vbloc.com or call 1-800-MY-VBLOC."Obesity and its comorbidities must be addressed in order to live a healthier and fuller life," said Dr. Maher. "Providing the best medical options to combat morbid obesity to the men and women who have served our country is a top priority and with vBloc Therapy available at the Richmond VAMC, we are now able to provide a safe and effective alternative to invasive, anatomy-altering and restricting procedures. There are well over one million veterans with obesity and the Richmond VAMC is committed to helping those in our communities succeed in their fight against obesity."

The vBloc System works to control sensations of hunger using a pacemaker-like device that is implanted under the skin during a safe, minimally-invasive procedure that does not alter or remove any patient anatomy. The device can be adjusted to optimize patients' therapy needs and works to give the patient a sensation of fullness, empowering them to eat less, control their appetite, and lose weight. Studies have shown that vBloc Therapy produces meaningful weight loss in patients as well as meaningful improvements in related comorbidity factors, such as HbA1c, without the major lifestyle implications of traditional weight loss surgeries.

"One in ten Virginians is a veteran and the State has the fastest growing veterans' population in the Nation," said Dan Gladney, EnteroMedics President, Chief Executive Officer and Chairman of the Board. "With our first implant at the Richmond VAMC, we are making vBloc accessible to an even larger portion of the men and women who have served our country selflessly and are in need of solutions to address their obesity. Through our previously announced partnership with Academy Medical, eligible veterans are able to receive vBloc Therapy at little to no cost. We look forward to working with other VA medical centers and VA Choice facilities so they can offer this state-of-the art weight loss treatment."

vBloc Therapy is approved for use in helping with weight loss in people aged 18 years and older who are obese, with a BMI of 40 to 45 kg/m2, or a BMI of 35 to 39.9 kg/m2 with a related health condition such as Type 2 diabetes, high blood pressure, high cholesterol levels or obstructive sleep apnea who have had a poor response to trying to lose weight under supervision in the last 5 years.

About McGuire Veterans Affairs Medical Center
The McGuire Veterans Affairs Medical Center is home to the latest and most sophisticated medical equipment and facilities for health care delivery for our Nation's Heroes. Last year, the medical center served nearly 60,000 veterans and active duty service members with more than 700,000 visits. Over 80% of the medical center's research has a direct impact on patient care studies in the VA system and in the community. The medical center also provides outpatient services through the Fredericksburg, Emporia, and Charlottesville VA Community Based Outpatient Clinics.

About EnteroMedics Inc.
EnteroMedics is a medical device company focused on the development and commercialization of its neuroscience based technology to treat obesity and metabolic diseases. vBloc® Neurometabolic Therapy, delivered by a pacemaker-like device called the vBloc® System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. EnteroMedics' vBloc® System has received U.S. Food and Drug Administration approval and CE Mark.

Information about the vBloc® System and vBloc® Neurometabolic Therapy
You should not have an implanted vBloc® System if you have cirrhosis of the liver, high blood pressure in the veins of the liver, enlarged veins in your esophagus or a significant hiatal hernia of the stomach; if you need magnetic resonance imaging (MRI); if you have a permanently implanted, electrical medical device; or if you need a diathermy procedure using heat. The most common related adverse events that were experienced during clinical study of the vBloc System included pain, heartburn, nausea, difficulty swallowing, belching, wound redness or irritation, and constipation.

Talk with your doctor about the full risks and benefits of vBloc Therapy and vBloc System. For additional prescribing information, please visit www.enteromedics.com.

If you are interested in learning more about vBloc Neurometabolic Therapy, please visit www.vbloc.com or call 1-800-MY-VBLOC. 

Read more...
GE to help over 200 hospitals in Egypt with 700 units of its advanced healthcare technologies (15.05.2017)

As part of Egypt’s vision to improve the quality and availability of healthcare in country, the government set forth an ambitious development plan that aims to avail and improve public healthcare services in each governate across Egypt.


Under this plan, GE Healthcare signed a key deal in Berlin, worth 25.8 million USD, to supply more than 200 Egyptian hospitals with a wide range of GE Healthcare’s technologies. GE will deliver and supply 700 units nationwide by the end of 2017, additionally GE will provide training to more than 1,200 doctors, technicians and nurses who will be the end users to operate these technologies.

According to an article by the World Health Organization, noncommunicable diseases (NCDs) are estimated to account for 82% of all deaths in Egypt and 67% of premature deaths. Supporting Egypt’s focus on earlier diagnosis and treatment on NDCs, GE Healthcare will supply various technologies from its portfolio to hospitals across Egypt.

These will include: GE’s Discovery IQ PET/CT which is the company’s advanced technology in early diagnosis and treatment follow up for oncology & advanced scanning techniques for neurology and cardiology; cSound, which is a new imaging platform to improve the quality of cardiovascular ultrasounds; GE’s SIGNA Explorer MR which delivers exceptional image quality, enhanced patient comfort and helps improve workflow and simplify operations; GE’s Carestation 620 which is compact, economical and easy to use anesthesia system designed to suit the smallest of spaces.

Some of the technologies provided by GE Healthcare under this agreement are being installed for the first time at the Ministry of Health hospitals, reflecting GE’s continued commitment to help its partners achieve their vision towards healthcare development in Egypt. To date, more than 400 units have already been distributed to hospitals across Egypt and GE is expected to complete the delivery and installation of the remaining units across military, Ministry of Health and university hospitals by the end of 2017.

Tamer Said, Regional Leader for GE Healthcare for North East Africa, added: “We are honored to be able to play an active role with our partners to elevate the quality and availability of healthcare services available to Egyptians. We understand the country’s needs and we’re keen on bringing GE Healthcare’s advanced capabilities and solutions to Egypt with speed and efficiency.

Additionally, we are committed to providing training to help build local know how and expertise of healthcare professionals to maximize the full features and benefits of these technologies to support clinicians in improving patient outcomes.”

The development of Egypt’s healthcare system has progressed significantly over the last decade. The Egyptian government has put the creation of a fairer healthcare system and improved patient care at the forefront of public policy in recent years, working with international organizations such as GE to help improve access to healthcare for the most vulnerable in the community.GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Today, more than 14,400 GE Healthcare technologies are deployed across hospitals and clinics in Egypt.
Read more...
Vyome Biosciences Completes Enrollmentfor Proof of Concept Clinical Study of VB-1953 (26.04.2017)
Vyome Biosciences, a clinical-stage specialty pharmaceutical company developing novel medicines for treating skin diseases caused by resistant microbes, today announced it completed enrollment in its proof-of-concept study ofVB1953, a topically administered gel, for patients with moderate to severe acne. The first patient was dosed in January and results are expected to be available later this year. 
  
A total of 161 patients with moderate to severe acne have been enrolled in the randomized, double-blind, vehicle-controlled study being conducted in three sites in Central America and the Dominican Republic. The study is comprised of four arms. In arm one of the study, 64 patients will receive the 2 percent VB 1953 topical gel applied once daily, while in the second arm, 64 patients will apply the 2 percent VB 1953 topical gel twice daily. In the third and fourth arms, 32 patients in each armwill receive vehicle gel once or twice daily, respectively. 

The primary objective of the study is to compare efficacy, tolerability and safety of VB1953 versus vehicle gel applied topically once or twice daily for up to 12 weeks.The primary endpoints of the study are change in inflammatory and non-inflammatory lesions from baseline to week 12, as well as percentage of patients with IGA success to week 12, compared to vehicle. 

“In prior studies, VB 1953 has shown potential to treat moderate to severe acne with a promising dermal safety signal and tolerability, and we look forward to demonstrating efficacy in this proof-of-concept clinical study as we work to develop a much-needed therapeutic option for these patients,” said Venkateswarlu Nelabhotla (N. Venkat), co-founder and chief executive officer of Vyome Biosciences. 

VB 1953 is a potent next-generation antibiotic and anti-inflammatory compound combined with a patented micro-technology gel system designed to maximize effect at the site of infection and minimize systemic exposure. As a topical treatment option, VB 1953 exerts an anti-inflammatory effect and impedes the development of resistance. In a U.S.-based phase 1 clinical trial conducted in 12 patients with moderate to severe acne receiving 14 days of treatment, VB 1953 met its primary endpoint relative to pharmacokinetics, achieving plasma concentration less than 1 ng/ml and dermal tolerability.  In addition to demonstrating safety, treatment with VB 1953 resulted in a reduction of inflammatory and non-inflammatory lesions, as well as a reduction in IGA scores, compared to baseline that were suggestive of a potential efficacy signal.

Following completion of the proof-of-concept study, Vyome plans to initiate a phase 2B trial to further evaluate VB 1953 for the treatment of moderate to severe acneby the end of 2017. 

About Acne
Approximately 240 million people are diagnosed with moderate to severe acne, with nearly 40 percent of those patients suffering from antibiotic resistance. According to the American Academy of Dermatology, acne represents the most common skin disease, affecting 40-50 million people in the United States, including 85 percent of teenagers. 

About Vyome Biosciences
Vyome Biosciences is an innovation-driven, clinical stage bio-pharmaceutical company, which has novel platforms technologies and a deep pipeline of novel drugs for antibiotic resistant acne, other opportunistic pathogens and antifungal agents in dermatology. Vyome has a deep pipeline of preclinical new chemical entities, unique in their ability to overcome the development of resistance based on its patented Dual Action Rational Therapeutics (DARTs) technology. Vyome has developed clinically proven antifungal products based on innovative technology platform Molecular Replacement Therapeutics (MRT™). Vyome has assembled a world-class team of scientific and business development experts from India and the United States who have a track record of conducting scientific research, developing breakthrough products and building sustainable businesses. More information is available at http://www.vyome.in
Read more...

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