A FEW PAST POSTS WORTH REVIEWING:
Endonovo Announces First Commercial Sales for SofPulse Wearable Electroceutical for Post-Operative Pain and Edema
GLOBENEWSWIRE 7:00 AM ET 1/22/2018
Symbol Last Price Change
ENDV 0.057up 0 (0%)
QUOTES AS OF 03:57:19 PM ET 01/19/2018
Seeking Distribution Partners in Europe for CE-Marked Electroceutical™ Device for Promotion of Wound Healing, Reduction of Pain and Post-Operative Edema
LOS ANGELES, CA, Jan. 22, 2018 (GLOBE NEWSWIRE) -- Endonovo Therapeutics(ENDV), Inc. ("Endonovo" or the "Company"
, a commercial-stage developer of non-invasive wearable Electroceutical™ devices, today announced the first commercial sales of SofPulse™, its non-invasive, wearable Electroceutical™ device. SofPulse™ is the Company's FDA-Cleared Electroceutical™ System for the palliative treatment of post-operative pain and edema in superficial soft tissues. Furthermore, the Company announced it is seeking distribution partners in Europe for SofPulse™, which is CE-Marked for the promotion of wound healing, reduction of pain and post-operative edema.
"We are very excited to begin sales of SofPulse™ under Endonovo management," said Endonovo CEO, Alan Collier. "Our wearable Electroceutical™ was FDA-Cleared in 2008, but no significant effort to commercialize this revolutionary technology was ever undertaken. SofPulse™ has shown 80% acceleration in pain relief in breast augmentation patients and 2-fold less narcotics use in breast reconstruction patients."
"As we battle an opioid epidemic we must look for novel ways to relieve pain for people suffering from chronic pain, as well as preventing people undergoing surgical procedures from becoming dependent on narcotics. We believe our wearable Electroceutical™ can drastically reduce the need for pain medication use and improve the lives of millions of people suffering from pain."
"Unlike many of our competitors using electrical stimulation, some of whom have signed agreements with large device and pharmaceutical companies, our devices don't simply mask the pain, they address the underlying issue causing the pain, which is inflammation," stated Mr. Collier.
"We are actively seeking to establish channel partnerships with global device and healthcare companies to commercialize our wearable Electroceuticals™ in Europe," concluded Mr. Collier.
About SofPulse™ Electroceutical™ System
SofPulse™ is an easy-to-place, non-invasive device that delivers targeted MicroCurrent Therapy (tMCT) to enhance post-surgical recovery, naturally. tMCT is an innovative process that uses proprietary technology to reduce pain and swelling. The therapy is non-invasive and non-pharmacologic, with no known side effects and no potential for overdose or dependency. SofPulse™ has been used effectively and studied extensively in soft tissue post-operative management. The low levels of microcurrent are completely safe and in fact, are 1000 times lower than those emitted by a mobile phone. SofPulse™ is manufactured, marketed and distributed through ADM Tronics Unlimited, Inc.
The Company's wearable Electroceuticals™ have been evaluated in 5 randomized, controlled clinical trials and have demonstrated significant reductions in pain, post-surgical edema and use of pain medication.
About Endonovo Therapeutics(ENDV)
Endonovo Therapeutics, Inc. (ENDV) is a commercial-stage developer of non-invasive wearable Electroceuticals™. The Company's current portfolio of commercial and clinical-stage wearable Electroceuticals™ addresses wound healing, pain, post-surgical edema and Central Nervous System (CNS) Disorders, including traumatic brain injury (TBI), acute concussions, post-concussion syndrome and multiple sclerosis. The Company's non-invasive Electroceutical™ device using pulsed short-wave radiofrequency at 27.12 MHz has been FDA-Cleared and CE Marked for the palliative treatment of soft tissue injuries and post-operative pain and edema, and has CMS National Coverage for the treatment of chronic wounds. The Company's current portfolio of pre-clinical stage Electroceuticals™ addresses chronic kidney disease, liver disease, cardiovascular and peripheral artery disease. The Company's non-invasive, wearable Electroceuticals™ work by restoring key electrochemical processes that initiate anti-inflammatory and growth factor cascades necessary for healing to occur.
ANOTHER:
Go NEWS!
Endonovo Therapeutics Provides Corporate Update and 2018 Outlook
Jan 16, 2018
OTC Disclosure & News Service
-
- Announces Series C Preferred Stock Offering
- Updates Status of Clinical Pipeline in Central Nervous System Disorders
LOS ANGELES, CA, Jan. 16, 2018 (GLOBE NEWSWIRE) -- - Endonovo Therapeutics, Inc. (OTCQB: ENDV) ("Endonovo" or the "Company", a clinical-stage developer of non-invasive electroceutical devices for the treatment of central nervous system (CNS) disorders, has provided a corporate update and outlook for 2018.
Plans to Complete Clinical Trial to Study Effects of tPEMF in Patients with Brain Injury
Endonovo plans to complete a single center, prospective, controlled, clinical trial of tPEMF to evaluate the effects of tPEMF in patients with brain injury and external ventricular drain (EVD) in an intensive care unit (ICU) setting. This clinical study is an extension of a safety trial and will be open to all patients who have or are fitted with an external ventricular drain (EVD) to remove excess cerebrospinal fluid (CSF).
Redesign tPEMF Products for Use in Central Nervous System Disorders
Endonovo plans to redesign tPEMF products for use in CNS disorders in order to make its tPEMF therapy easier to use and increase patient compliance. Endonovo believes that industrial design and engineering of non-invasive electroceutical devices will be a critical component to the precise stimulation of areas in the CNS that require treatment and allow patients to use the therapy in an in-home setting.
Initiate Previously Planned Studies of tPEMF in Post-Concussion Syndrome and Acute Concussions
Endonovo plans to initiate previously planned clinical trials to study the effects of tPEMF in patients with Post-Concussion Syndrome (PCS) and Acute Sports-related Concussions upon the redesign of its tPEMF devices for use in CNS disorders.
Initiate Previously Planned Feasibility Study for Use of tPEMF In Patients with Multiple Sclerosis
Endonovo plans to initiate an open-label study of tPEMF treatment in patients with multiple sclerosis (MS) that will be used to assess feasibility and tolerability of tPEMF therapy and to generate preliminary data on clinically relevant outcomes.
Pursuing Licensing, Distribution, and Partnership Opportunities for FDA-Cleared Devices
Endonovo plans to commercialize its CE-Marked and FDA-Cleared Electroceutical™ therapy in China, Japan, Korea and other international markets. Endonovo has already initiated dialogue with potential licensees, distributors and joint venture partners in Asia. Endonovo will further look to establish distribution agreements and licenses in the Unites States for cosmetic surgery and orthopedic indications or explore the establishment of its own sales and marketing channels.
Announces Series C Preferred Stock Offering
Endonovo has announced a Senior Secured Series C Preferred Stock Offering (the "Series C Stock" to raise up to $8 million in funding. The Series C Stock is a fixed-price redeemable preferred stock that accrues an 8% dividend per annum paid in quarterly installments. The Series C Stock contains two year warrants to purchase common shares, the number of warrants will be such number as to have an aggregate exercise price equal to 20% of the purchase price of the Series C Stock. The exercise price of the warrants will be the closing price of Endonovo's common stock on the date Endonovo receives fully executed closing documents from purchasers of the Series C Stock and the subscription amount. To date, Endonovo has raised approximately $1 million of the Series C Stock. For more information on the Series C Stock, interested parties can find the Company contact information below.
Management Commentary
"2017 was a pivotal year for Endonovo, which saw the company position itself as a clinical stage developer of non-invasive Electroceutical therapies by acquiring a portfolio of intellectual property, a clinical pipeline in central nervous system disorders, and FDA-Cleared and CE Marked products," said Alan Collier, Co-Founder and CEO of Endonovo Therapeutics.
"Now having completed this acquisition, we are looking to position the company for continued growth by redeeming our outstanding convertible notes and uplisting the company onto a national stock exchange where we can increase shareholder value."
"As we prepare restarting and completing a previously on-going clinical trial to evaluate our non-invasive medical devices in brain injury, we will also work to initiate several previously planned clinical trials to evaluate our Electroceuticals in other CNS disorders."
"The market for CNS therapies currently lacks effective treatments for many CNS disorders, such as traumatic brain injuries and stroke because of the difficulty in delivering efficacious amounts of drugs to the brain. However, our highly differentiated and non-invasive approach is not limited by the blood-brain barrier to deliver our therapy to the central nervous system, which presents a significant opportunity for Endonovo to capture a significant share of the CNS therapeutics market estimated to be worth $128.9 billion by 2025."
2018 Expected Milestones
· Restart clinical trial for tPEMF treatment in patients with brain injury and external ventricular drain (EVD)
· Initiate clinical trial for tPEMF treatment in patients with Post-Concussion Syndrome
· Initiate clinical trial for tPEMF treatment in patients with acute sports-related concussions
· Initiate pilot clinical trial for tPEMF treatment in patients with relapsing forms of multiple sclerosis
· 1-2 license agreements to be signed by the end of 2018
· Uplist the Company's common stock onto a national stock exchange
About Targeted-Pulsed Electromagnetic Fields (tPEMF)
Targeted-Pulsed Electromagnetic Fields (tPEMF) use radiofrequency waves at 27.12 MHz to deliver electromagnetic energy to tissues. The Company's tPEMF technology works by restoring key electrochemical process that initiate the anti-inflammatory and growth factor cascades necessary for healing to occur. tPEMF technology has been shown to accelerate the production of the endogenous constitutive nitric oxide synthase systems (cNOS): the anti-inflammatory system, resulting in increased blood and lymph flow, and decreased pain and edema.
The Company's tPEMF technology has been evaluated in 5 randomized controlled clinical trials and has demonstrated significant reductions in pain, edema and use of pain medication.
In pre-clinical studies of neuroinflammation and brain injury, the Company's tPEMF technology has demonstrated significant reduction of neuroinflammation, including a 5-fold reduction of IL-1 beta, a master regulator of neuroinflammation, when compared to untreated animals. Furthermore, in pre-clinical studies of angiogenesis (promotion of new blood vessels), the Company's tPEMF technology demonstrated a 500 percent increase in angiogenesis at 8 weeks.
An Overview of the Company's tPEMF Technology can be found in the presentations page on the Investor Section of the Company's website.
ANOTHER:
Here is a breakdown in layman terms of the presentation data:
Page 4: These are the photos of the hearts showing that TVEMF prevented or reduced the heart from enlarging following MI. The control hearts on the left are visibly much larger than the ones treated with TVEMF.
Page 5: This chart demonstrates the heart-weight-to-body-weight ratio (HW/BW), which is an index for hypertrophy (growth of the heart). As seen the HW/BW of the control is significantly larger than HW/BW ratio for those treated with TVEMF.
Page 6: LVDP = Left Ventricular Diastolic Pressure, which is a measurement of blood pressure within the ventricle. This is showing that TVEMF treatment significantly increase the contraction of the heart as evidenced by more blood pressure during the contraction. After MI, the heart is weak. The chart on the right is this measurement in relation to time (time derivative).
Page 7: Fractional Shortening = simply put is the shortening of the end-diastolic diameter that occurs by the end of systole (contraction). Ventricular diastole is the period during which the ventricles are filling and relaxing. So a higher fractional shortening allows more blood flow. If the diameter fails to shorten by at least 28%, the efficiency of the heart in ejecting blood is impaired. We can see from the chart that the control group had impaired FS and that TVEMF treatment significantly increases FS.
Ejection Fraction = the fraction of all blood in the ventricle that is ejected at each heart beat. The normal EF of the left ventricle is 65%, I don't know what it is for mice, but should be similar. The chart shows that the control group had very significant reduction of EF and that TVEMF treated animals had significantly higher EF, which is improved heart function and blood flow.
Page 8: left ventricular end-systolic diameter is measured at end systole (contraction). It corresponds to the smallest cardiac dimension. LVESD is a marker of left ventricular function. Following MI, the ventricle will be dilated and reduce contraction and blood ejection. Based on the chart TVEMF significantly reduced dilation of the left ventricle.
Page 9: This shows there was repair to the septum measured at the end of contraction. A thicker interventricular septal thickness measured at systole equates to a heart function and repair.
So all in all, we good results. Can't wait until tomorrow to see what will happen once the news has been digested over the weekend. Looking forward to stealing day trader shares.
Endonovo Announces First Commercial Sales for SofPulse Wearable Electroceutical for Post-Operative Pain and Edema
GLOBENEWSWIRE 7:00 AM ET 1/22/2018
Symbol Last Price Change
ENDV 0.057up 0 (0%)
QUOTES AS OF 03:57:19 PM ET 01/19/2018
Seeking Distribution Partners in Europe for CE-Marked Electroceutical™ Device for Promotion of Wound Healing, Reduction of Pain and Post-Operative Edema
LOS ANGELES, CA, Jan. 22, 2018 (GLOBE NEWSWIRE) -- Endonovo Therapeutics(ENDV), Inc. ("Endonovo" or the "Company"
, a commercial-stage developer of non-invasive wearable Electroceutical™ devices, today announced the first commercial sales of SofPulse™, its non-invasive, wearable Electroceutical™ device. SofPulse™ is the Company's FDA-Cleared Electroceutical™ System for the palliative treatment of post-operative pain and edema in superficial soft tissues. Furthermore, the Company announced it is seeking distribution partners in Europe for SofPulse™, which is CE-Marked for the promotion of wound healing, reduction of pain and post-operative edema. "We are very excited to begin sales of SofPulse™ under Endonovo management," said Endonovo CEO, Alan Collier. "Our wearable Electroceutical™ was FDA-Cleared in 2008, but no significant effort to commercialize this revolutionary technology was ever undertaken. SofPulse™ has shown 80% acceleration in pain relief in breast augmentation patients and 2-fold less narcotics use in breast reconstruction patients."
"As we battle an opioid epidemic we must look for novel ways to relieve pain for people suffering from chronic pain, as well as preventing people undergoing surgical procedures from becoming dependent on narcotics. We believe our wearable Electroceutical™ can drastically reduce the need for pain medication use and improve the lives of millions of people suffering from pain."
"Unlike many of our competitors using electrical stimulation, some of whom have signed agreements with large device and pharmaceutical companies, our devices don't simply mask the pain, they address the underlying issue causing the pain, which is inflammation," stated Mr. Collier.
"We are actively seeking to establish channel partnerships with global device and healthcare companies to commercialize our wearable Electroceuticals™ in Europe," concluded Mr. Collier.
About SofPulse™ Electroceutical™ System
SofPulse™ is an easy-to-place, non-invasive device that delivers targeted MicroCurrent Therapy (tMCT) to enhance post-surgical recovery, naturally. tMCT is an innovative process that uses proprietary technology to reduce pain and swelling. The therapy is non-invasive and non-pharmacologic, with no known side effects and no potential for overdose or dependency. SofPulse™ has been used effectively and studied extensively in soft tissue post-operative management. The low levels of microcurrent are completely safe and in fact, are 1000 times lower than those emitted by a mobile phone. SofPulse™ is manufactured, marketed and distributed through ADM Tronics Unlimited, Inc.
The Company's wearable Electroceuticals™ have been evaluated in 5 randomized, controlled clinical trials and have demonstrated significant reductions in pain, post-surgical edema and use of pain medication.
About Endonovo Therapeutics(ENDV)
Endonovo Therapeutics, Inc. (ENDV) is a commercial-stage developer of non-invasive wearable Electroceuticals™. The Company's current portfolio of commercial and clinical-stage wearable Electroceuticals™ addresses wound healing, pain, post-surgical edema and Central Nervous System (CNS) Disorders, including traumatic brain injury (TBI), acute concussions, post-concussion syndrome and multiple sclerosis. The Company's non-invasive Electroceutical™ device using pulsed short-wave radiofrequency at 27.12 MHz has been FDA-Cleared and CE Marked for the palliative treatment of soft tissue injuries and post-operative pain and edema, and has CMS National Coverage for the treatment of chronic wounds. The Company's current portfolio of pre-clinical stage Electroceuticals™ addresses chronic kidney disease, liver disease, cardiovascular and peripheral artery disease. The Company's non-invasive, wearable Electroceuticals™ work by restoring key electrochemical processes that initiate anti-inflammatory and growth factor cascades necessary for healing to occur.
ANOTHER:
Go NEWS!
Endonovo Therapeutics Provides Corporate Update and 2018 Outlook
Jan 16, 2018
OTC Disclosure & News Service
-
- Announces Series C Preferred Stock Offering
- Updates Status of Clinical Pipeline in Central Nervous System Disorders
LOS ANGELES, CA, Jan. 16, 2018 (GLOBE NEWSWIRE) -- - Endonovo Therapeutics, Inc. (OTCQB: ENDV) ("Endonovo" or the "Company"
, a clinical-stage developer of non-invasive electroceutical devices for the treatment of central nervous system (CNS) disorders, has provided a corporate update and outlook for 2018. Plans to Complete Clinical Trial to Study Effects of tPEMF in Patients with Brain Injury
Endonovo plans to complete a single center, prospective, controlled, clinical trial of tPEMF to evaluate the effects of tPEMF in patients with brain injury and external ventricular drain (EVD) in an intensive care unit (ICU) setting. This clinical study is an extension of a safety trial and will be open to all patients who have or are fitted with an external ventricular drain (EVD) to remove excess cerebrospinal fluid (CSF).
Redesign tPEMF Products for Use in Central Nervous System Disorders
Endonovo plans to redesign tPEMF products for use in CNS disorders in order to make its tPEMF therapy easier to use and increase patient compliance. Endonovo believes that industrial design and engineering of non-invasive electroceutical devices will be a critical component to the precise stimulation of areas in the CNS that require treatment and allow patients to use the therapy in an in-home setting.
Initiate Previously Planned Studies of tPEMF in Post-Concussion Syndrome and Acute Concussions
Endonovo plans to initiate previously planned clinical trials to study the effects of tPEMF in patients with Post-Concussion Syndrome (PCS) and Acute Sports-related Concussions upon the redesign of its tPEMF devices for use in CNS disorders.
Initiate Previously Planned Feasibility Study for Use of tPEMF In Patients with Multiple Sclerosis
Endonovo plans to initiate an open-label study of tPEMF treatment in patients with multiple sclerosis (MS) that will be used to assess feasibility and tolerability of tPEMF therapy and to generate preliminary data on clinically relevant outcomes.
Pursuing Licensing, Distribution, and Partnership Opportunities for FDA-Cleared Devices
Endonovo plans to commercialize its CE-Marked and FDA-Cleared Electroceutical™ therapy in China, Japan, Korea and other international markets. Endonovo has already initiated dialogue with potential licensees, distributors and joint venture partners in Asia. Endonovo will further look to establish distribution agreements and licenses in the Unites States for cosmetic surgery and orthopedic indications or explore the establishment of its own sales and marketing channels.
Announces Series C Preferred Stock Offering
Endonovo has announced a Senior Secured Series C Preferred Stock Offering (the "Series C Stock"
to raise up to $8 million in funding. The Series C Stock is a fixed-price redeemable preferred stock that accrues an 8% dividend per annum paid in quarterly installments. The Series C Stock contains two year warrants to purchase common shares, the number of warrants will be such number as to have an aggregate exercise price equal to 20% of the purchase price of the Series C Stock. The exercise price of the warrants will be the closing price of Endonovo's common stock on the date Endonovo receives fully executed closing documents from purchasers of the Series C Stock and the subscription amount. To date, Endonovo has raised approximately $1 million of the Series C Stock. For more information on the Series C Stock, interested parties can find the Company contact information below. Management Commentary
"2017 was a pivotal year for Endonovo, which saw the company position itself as a clinical stage developer of non-invasive Electroceutical therapies by acquiring a portfolio of intellectual property, a clinical pipeline in central nervous system disorders, and FDA-Cleared and CE Marked products," said Alan Collier, Co-Founder and CEO of Endonovo Therapeutics.
"Now having completed this acquisition, we are looking to position the company for continued growth by redeeming our outstanding convertible notes and uplisting the company onto a national stock exchange where we can increase shareholder value."
"As we prepare restarting and completing a previously on-going clinical trial to evaluate our non-invasive medical devices in brain injury, we will also work to initiate several previously planned clinical trials to evaluate our Electroceuticals in other CNS disorders."
"The market for CNS therapies currently lacks effective treatments for many CNS disorders, such as traumatic brain injuries and stroke because of the difficulty in delivering efficacious amounts of drugs to the brain. However, our highly differentiated and non-invasive approach is not limited by the blood-brain barrier to deliver our therapy to the central nervous system, which presents a significant opportunity for Endonovo to capture a significant share of the CNS therapeutics market estimated to be worth $128.9 billion by 2025."
2018 Expected Milestones
· Restart clinical trial for tPEMF treatment in patients with brain injury and external ventricular drain (EVD)
· Initiate clinical trial for tPEMF treatment in patients with Post-Concussion Syndrome
· Initiate clinical trial for tPEMF treatment in patients with acute sports-related concussions
· Initiate pilot clinical trial for tPEMF treatment in patients with relapsing forms of multiple sclerosis
· 1-2 license agreements to be signed by the end of 2018
· Uplist the Company's common stock onto a national stock exchange
About Targeted-Pulsed Electromagnetic Fields (tPEMF)
Targeted-Pulsed Electromagnetic Fields (tPEMF) use radiofrequency waves at 27.12 MHz to deliver electromagnetic energy to tissues. The Company's tPEMF technology works by restoring key electrochemical process that initiate the anti-inflammatory and growth factor cascades necessary for healing to occur. tPEMF technology has been shown to accelerate the production of the endogenous constitutive nitric oxide synthase systems (cNOS): the anti-inflammatory system, resulting in increased blood and lymph flow, and decreased pain and edema.
The Company's tPEMF technology has been evaluated in 5 randomized controlled clinical trials and has demonstrated significant reductions in pain, edema and use of pain medication.
In pre-clinical studies of neuroinflammation and brain injury, the Company's tPEMF technology has demonstrated significant reduction of neuroinflammation, including a 5-fold reduction of IL-1 beta, a master regulator of neuroinflammation, when compared to untreated animals. Furthermore, in pre-clinical studies of angiogenesis (promotion of new blood vessels), the Company's tPEMF technology demonstrated a 500 percent increase in angiogenesis at 8 weeks.
An Overview of the Company's tPEMF Technology can be found in the presentations page on the Investor Section of the Company's website.
ANOTHER:
Here is a breakdown in layman terms of the presentation data:
Page 4: These are the photos of the hearts showing that TVEMF prevented or reduced the heart from enlarging following MI. The control hearts on the left are visibly much larger than the ones treated with TVEMF.
Page 5: This chart demonstrates the heart-weight-to-body-weight ratio (HW/BW), which is an index for hypertrophy (growth of the heart). As seen the HW/BW of the control is significantly larger than HW/BW ratio for those treated with TVEMF.
Page 6: LVDP = Left Ventricular Diastolic Pressure, which is a measurement of blood pressure within the ventricle. This is showing that TVEMF treatment significantly increase the contraction of the heart as evidenced by more blood pressure during the contraction. After MI, the heart is weak. The chart on the right is this measurement in relation to time (time derivative).
Page 7: Fractional Shortening = simply put is the shortening of the end-diastolic diameter that occurs by the end of systole (contraction). Ventricular diastole is the period during which the ventricles are filling and relaxing. So a higher fractional shortening allows more blood flow. If the diameter fails to shorten by at least 28%, the efficiency of the heart in ejecting blood is impaired. We can see from the chart that the control group had impaired FS and that TVEMF treatment significantly increases FS.
Ejection Fraction = the fraction of all blood in the ventricle that is ejected at each heart beat. The normal EF of the left ventricle is 65%, I don't know what it is for mice, but should be similar. The chart shows that the control group had very significant reduction of EF and that TVEMF treated animals had significantly higher EF, which is improved heart function and blood flow.
Page 8: left ventricular end-systolic diameter is measured at end systole (contraction). It corresponds to the smallest cardiac dimension. LVESD is a marker of left ventricular function. Following MI, the ventricle will be dilated and reduce contraction and blood ejection. Based on the chart TVEMF significantly reduced dilation of the left ventricle.
Page 9: This shows there was repair to the septum measured at the end of contraction. A thicker interventricular septal thickness measured at systole equates to a heart function and repair.
So all in all, we good results. Can't wait until tomorrow to see what will happen once the news has been digested over the weekend. Looking forward to stealing day trader shares.
