BIEL follows up on better disclosure to shareholde
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Posted On: 06/04/2019 10:58:52 AM
BIEL follows up on better disclosure to shareholders...
Investors Update for publication week of June 3, 2019
General Update
We have been invited to present ActiPatch at WalMart’s Open Call 2019 for new products on June 18th & 19th. Our VP of Sales/Marketing, Keith Nalepka, will be making the presentation.
CE Mark Status Update
Owing to ongoing changes in CE mark regulations, there has been a severe backlog in the CE mark review process of the medical device industry. There are two parts required to meet the current CE mark requirements: 1) Technical file, which provides evidence of safety and effectiveness 2) ISO certification, which provides of a validated quality management system (QMS). We are currently in the interactive review process of our technical file with the notified body, NEMKO/Presafe. We anticipate achieving the technical file certification within the next 6-8 weeks.
Our manufacturer in China has initiated the process of ISO certification for their facility, which satisfies the QMS requirement aspect of the CE mark. This will allow BIEL to manufacture, package, and ship products for all non-US markets directly from China, thus streamlining the process and saving time/money.
Achieving these two certifications will result in our notified body (Presafe) issuing BioElectronics a CE certificate. We anticipate obtaining this in mid-late July.
FDA Market Clearance Updates
Post-Operative Pain
The postoperative pain 510(k) application was submitted in February 2019. Since postoperative pain is an acute pain condition, the FDA requested additional statistical analyses and medication consumption data from the cesarean section, and breast augmentation studies to allow for comparisons with pain reduction rates in the placebo group. Our responses, including the requested analyses, were submitted to the FDA on May 29, 2019. Prior response times indicate that the FDA should review our information within the next few weeks. The Company’s responses were handled by a team led by Dr. Koneru and consisting of Dr. Rawe, Dr. Staelin, and Dr. McLeod.
Obtaining postoperative pain clearance will be a big victory for the Company because it gives us the opportunity to market RecoveryRx in both the surgical and chronic wound markets.
The post-operative market opportunities are:
Drug-free postoperative analgesic therapy to spare opioid/NSAID use for the more than 15 million Americans who undergo 22 million surgeries annually.
Hip & Knee Replacement Surgeries. There are more than 1 million hip and knee replacement surgeries performed each year. Based on B. Braun’s Total Pathways program, the potential is 30 million devices.
C-Sections represents 32% of all births in US amounting to approximately 1.2 million procedures. RecoveryRx will help women achieve lower pain levels quicker and spare opioid/NSAID use
Chronic wounds which are generally surgically debrided (removing of unhealthy tissue) creating post procedural pain
Musculoskeletal Pain
BIEL submitted a back-pain study in mid-2018 to seek expanded musculoskeletal clearance building on the two prior clearances for knee osteoarthritis and plantar fasciitis (heel pain) in 2017. During the review, FDA indicated that randomization of men into active/placebo groups appeared unbalanced – a natural, but rare occurrence inherent to the process of randomization, such as flipping a coin 100 times and getting a significantly higher number of either heads or tails (one would expect 50-50). Upon taking a closer look at the data, the FDA indicated that the subsample of women responded well, but since randomization of men was unbalanced, results in the entire sample could not be evaluated adequately. Further, since the claim requested was for general musculoskeletal pain and not just for back pain, the FDA felt that it was not possible to compare results from the back-pain study to results from prior clearances (which included both men and women). Since the end of the review period was reached, the FDA issued a NSE letter while noting significance of results in women.
Subsequently, BIEL reviewed data from all three studies and found the FDA’s observations that the device was more effective in women, to be accurate. As a result, analyses on data for women from the back study, knee study and plantar fasciitis study were submitted for a separate 510(k) in February 2019, seeking indications for treatment of musculoskeletal pain in women. The FDA acknowledged that the data on women in all three studies indicated that a more favorable treatment response than in men. The FDA requested data on men also for all three studies, which the company duly provided. However, FDA was concerned about the smaller sample size of men in the studies and wanted to see more data on men to conclude that ActiPatch was indeed less effective in men. Further, since the observation of better effectiveness in women was post-hoc, FDA was concerned about using post-hoc analysis as the basis for regulatory purposes. FDA recommended an alternate study focused on evaluating sex differences specifically in both men and women.
At this time, interim data from a randomized clinical study investigating the effectiveness of ActiPatch in reducing neck osteoarthritis (https://clinicaltrials.gov/ct2/show/NCT03542955) became available to the Company. This data indicated that there was sufficient statistical evidence to seek expanded treatment indications on both men and women. The Company conveyed to the FDA that it intends to submit the new data and replace women-only treatment indications with treatment indications for both men and women. However, the FDA responded that it would not have adequate time to exhaustively review the new data within the original 90-day review window and recommended that the current application be withdrawn, and a fresh application be submitted with the new data for expanded indications of “over-the counter treatment of general musculoskeletal pain”. General musculoskeletal pain includes, but is not limited to, pain located in the back, knee, shoulder, neck, wrist, elbow etc.
Neck Pain Study for New 510(k) application
The neck osteoarthritis study investigates the effectiveness of ActiPatch in reducing pain both in men and women and satisfies the FDA requirement for a third ActiPatch study on a different musculoskeletal location to get general musculoskeletal clearance, thus serving as a replacement for the back-pain study. The neck study directly compares the effectiveness of ActiPatch to that of prescription NSAID pills. Subjects were randomly assigned either to receive the standard of care treatment (cox-2 inhibitor) or ActiPatch. Interim results demonstrate that the ActiPatch is statistically significantly superior to the standard of care therapy in reducing neck pain. We anticipate submitting the new 510(k) in June 2019.
ActiPatch is already FDA-cleared for adjunctive treatment of pain from knee osteoarthritis (25 million) and plantar fasciitis (2 million annually). The expanded market clearance would allow ActiPatch to be marketed for a broad range of musculoskeletal conditions such as back pain (42 million), neck pain (19 million), hip pain (9 million), shoulder pain (11 million), carpal tunnel pain (12 million) and many other musculoskeletal complaints. Additionally, we are codeveloping braces and wraps that include our device to provide both compression and pain therapy to be sold to physical therapists and chiropractors.
Investors Update for publication week of June 3, 2019
General Update
We have been invited to present ActiPatch at WalMart’s Open Call 2019 for new products on June 18th & 19th. Our VP of Sales/Marketing, Keith Nalepka, will be making the presentation.
CE Mark Status Update
Owing to ongoing changes in CE mark regulations, there has been a severe backlog in the CE mark review process of the medical device industry. There are two parts required to meet the current CE mark requirements: 1) Technical file, which provides evidence of safety and effectiveness 2) ISO certification, which provides of a validated quality management system (QMS). We are currently in the interactive review process of our technical file with the notified body, NEMKO/Presafe. We anticipate achieving the technical file certification within the next 6-8 weeks.
Our manufacturer in China has initiated the process of ISO certification for their facility, which satisfies the QMS requirement aspect of the CE mark. This will allow BIEL to manufacture, package, and ship products for all non-US markets directly from China, thus streamlining the process and saving time/money.
Achieving these two certifications will result in our notified body (Presafe) issuing BioElectronics a CE certificate. We anticipate obtaining this in mid-late July.
FDA Market Clearance Updates
Post-Operative Pain
The postoperative pain 510(k) application was submitted in February 2019. Since postoperative pain is an acute pain condition, the FDA requested additional statistical analyses and medication consumption data from the cesarean section, and breast augmentation studies to allow for comparisons with pain reduction rates in the placebo group. Our responses, including the requested analyses, were submitted to the FDA on May 29, 2019. Prior response times indicate that the FDA should review our information within the next few weeks. The Company’s responses were handled by a team led by Dr. Koneru and consisting of Dr. Rawe, Dr. Staelin, and Dr. McLeod.
Obtaining postoperative pain clearance will be a big victory for the Company because it gives us the opportunity to market RecoveryRx in both the surgical and chronic wound markets.
The post-operative market opportunities are:
Drug-free postoperative analgesic therapy to spare opioid/NSAID use for the more than 15 million Americans who undergo 22 million surgeries annually.
Hip & Knee Replacement Surgeries. There are more than 1 million hip and knee replacement surgeries performed each year. Based on B. Braun’s Total Pathways program, the potential is 30 million devices.
C-Sections represents 32% of all births in US amounting to approximately 1.2 million procedures. RecoveryRx will help women achieve lower pain levels quicker and spare opioid/NSAID use
Chronic wounds which are generally surgically debrided (removing of unhealthy tissue) creating post procedural pain
Musculoskeletal Pain
BIEL submitted a back-pain study in mid-2018 to seek expanded musculoskeletal clearance building on the two prior clearances for knee osteoarthritis and plantar fasciitis (heel pain) in 2017. During the review, FDA indicated that randomization of men into active/placebo groups appeared unbalanced – a natural, but rare occurrence inherent to the process of randomization, such as flipping a coin 100 times and getting a significantly higher number of either heads or tails (one would expect 50-50). Upon taking a closer look at the data, the FDA indicated that the subsample of women responded well, but since randomization of men was unbalanced, results in the entire sample could not be evaluated adequately. Further, since the claim requested was for general musculoskeletal pain and not just for back pain, the FDA felt that it was not possible to compare results from the back-pain study to results from prior clearances (which included both men and women). Since the end of the review period was reached, the FDA issued a NSE letter while noting significance of results in women.
Subsequently, BIEL reviewed data from all three studies and found the FDA’s observations that the device was more effective in women, to be accurate. As a result, analyses on data for women from the back study, knee study and plantar fasciitis study were submitted for a separate 510(k) in February 2019, seeking indications for treatment of musculoskeletal pain in women. The FDA acknowledged that the data on women in all three studies indicated that a more favorable treatment response than in men. The FDA requested data on men also for all three studies, which the company duly provided. However, FDA was concerned about the smaller sample size of men in the studies and wanted to see more data on men to conclude that ActiPatch was indeed less effective in men. Further, since the observation of better effectiveness in women was post-hoc, FDA was concerned about using post-hoc analysis as the basis for regulatory purposes. FDA recommended an alternate study focused on evaluating sex differences specifically in both men and women.
At this time, interim data from a randomized clinical study investigating the effectiveness of ActiPatch in reducing neck osteoarthritis (https://clinicaltrials.gov/ct2/show/NCT03542955) became available to the Company. This data indicated that there was sufficient statistical evidence to seek expanded treatment indications on both men and women. The Company conveyed to the FDA that it intends to submit the new data and replace women-only treatment indications with treatment indications for both men and women. However, the FDA responded that it would not have adequate time to exhaustively review the new data within the original 90-day review window and recommended that the current application be withdrawn, and a fresh application be submitted with the new data for expanded indications of “over-the counter treatment of general musculoskeletal pain”. General musculoskeletal pain includes, but is not limited to, pain located in the back, knee, shoulder, neck, wrist, elbow etc.
Neck Pain Study for New 510(k) application
The neck osteoarthritis study investigates the effectiveness of ActiPatch in reducing pain both in men and women and satisfies the FDA requirement for a third ActiPatch study on a different musculoskeletal location to get general musculoskeletal clearance, thus serving as a replacement for the back-pain study. The neck study directly compares the effectiveness of ActiPatch to that of prescription NSAID pills. Subjects were randomly assigned either to receive the standard of care treatment (cox-2 inhibitor) or ActiPatch. Interim results demonstrate that the ActiPatch is statistically significantly superior to the standard of care therapy in reducing neck pain. We anticipate submitting the new 510(k) in June 2019.
ActiPatch is already FDA-cleared for adjunctive treatment of pain from knee osteoarthritis (25 million) and plantar fasciitis (2 million annually). The expanded market clearance would allow ActiPatch to be marketed for a broad range of musculoskeletal conditions such as back pain (42 million), neck pain (19 million), hip pain (9 million), shoulder pain (11 million), carpal tunnel pain (12 million) and many other musculoskeletal complaints. Additionally, we are codeveloping braces and wraps that include our device to provide both compression and pain therapy to be sold to physical therapists and chiropractors.
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