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https://www.nytimes.com/2023/01/27/business/paradigm-startup-clinical-trials.html
From today's NYT. Last year there were 430,000 FDA trials, in 2000 there were 2,000.
The article does not clarify if this means completed or ongoing trials. IPIX continues to be
a source of press releases, but little else. Maybe, maybe some Alfa Sigma news coming this year.
If they wanted to buy all or lots of the company they could, it is cheap at 2 cents. Maybe they would.
Actually, I believe they would, but have little to base this on.
Just left the AlfaSigma site on LinkedIn, nothing new re the testing of Brilacidin for IBD issues. Any news would have been nice. Probably good to do another Google search.
Gets harder and harder to take LE and friend seriously, except for the fact they have burned (Ok, mostly LE) maybe 65K of my investment cache. In the overall scheme of things that may not be much, but to me it sure is.
"I remain optimistic that we are going to see some very good things in 2023 beginning with tax loss sellers buying back in and ramping up the share price and followed by a deal or two bring in badly need cash. All good wishes for the new year."
Nice thoughts. If many tax loss sellers buy back, and at these prices I'm betting lots will, the buying period will probably go from early January to sometime in early February, i.e., at least 30 trading days after the tax loss sale and before the buy back. I thought about selling it all on December 1st and buying back after January first. But I didn't have enough stock winnings to make it all worthwhile, so I would have just written off $3,000 this tax year, and another $3,000 annually for the next 22 or so years. Just not worth the fuss, for me, at least. Good wishes for the upcoming year from me too .
Most BPs don't care about IPIX. If they did, many shares would have already been sucked up with or without Leo's agreement. Only AlfaSigma has really shown any concern, to date.
Whooa, up .003. Good news for bag holders. Gonna be a Merry Christmas, except for those I convinced to buy this whatever you call it. Hmm, maybe my boy will forget I had time "Take a few thousand shares" way back when.
".... this company is not going anywhere without funding news!!!!!!"
AlfaSigma. Not guaranteed, by far, but still a decent bet to have some
things in place and get you the fundable news we all crave. Just not sure Leo
and "company" (sounds strange to say that, uh?") really care as long as they
continue to squeeze the long green out of our hides.
Or, Leo is not so concerned with deals as long as he can continue to dilute and spit 1 million annually with a friend. A few more years likely, so maybe his selling price is based on that projection of at least 3 or 4 to10 million for the whole ball of wax. But really, is there any BP willing to front that? Maybe mid sized AlfaSigma would, if B tests our well for IBD variants. Agree BeaMed could be something real, but do we have enough info to make a realistic guess? So many ifs.
"When the nasal spray is finally formulated IPIX will be trading 10, 20, 100s million shares a day."
Not trying to p you off, but who is going to pay for this? And why? I agree, it would be a good thing, very useful. Hell, Leo could pay for it out of his and his buddy's paychecks, and still have lots left over. But how likely is that? As I said, who is likely to pay? Since it is not part of a saleable product I don't guess it has to go through an FDA 510, though it could easily as there must be other, substantially similar, nasal type sprays. But I'm no expert in this area, for sure. This is another reason why it is better to have a small lab with a post doc or two, than just being a shell company. But that train left the station a decade or more ago, I guess.
It kind of pains me to see this part data, PR issued. And the MMs wisely keep the pps down. What else would they do? I first turned from mildly positive to mildly negative on this stock when the Prurisol test was never fully accompanied by all available data. No reason given. Same old story. I still am looking ("hoping" may be a better word) to the Italian study, maybe next year, to pop and maybe rub off on IPIX a bit. IBD is such a huge market. Then B for ABSSSI (even OPM?) may have a real chance, though 30-40million for just the ABSSSI is quite an expenditure for a mostly shell company. But one can hope.
"......so why not allow Compassionate Use...."
The problem is someone has to know about IPIX for any use, compassionate or otherwise. Appearing in obscure journals will not make many aware of the potentials of any of its potential, as yet unapproved products. Better than nothing, but not by much it would seem. Still long.
"but the investment from Leo this past summer was probably well received. From 6/15/22 PR:"
I can easily believe this. The small company I contracted to help with 510s, a few years ago, would have jumped at 4 million, 1 million or lots less. Lots of pieces to put together, we still need to know how much each installation cost.
I can't find a picture of a BeaMed Unit, Am I missing it?
From the BeaMed web page, 2nd line below
Gil owns and manages neoLaser, a company he founded in 2012, and led to revenue growth and profitability with a 43% CAGR on its way to more than 1200 global installations and performing 50,000+ surgeries annually in over 30 countries. Previously Gil led product development and marketing at OmniGuide, a successful high-growth laser based medical device spin-off out of the Massachusetts Institute of Technology (MIT). Prior to OmniGuide Gil served as an officer in the Israeli Air Force, with responsibility for management of advanced technology projects. He holds an M.Sc in Electrical Engineering from Tel-Aviv University (Summa Cum Laude), a B.Sc in Electrical Engineering and B.A in Physics from the Technion, Israel Institute of Technology (both Summa Cum Laude) and an MBA from MIT, Sloan School of Management.
Moshe Eshkol
CTO
Moshe, a solid state physicist, did his PhD. Studies at the Tel Aviv University, has extensive knowledge of numerical simulations, FEA analysis and optical and mechanical design.
Read more
Moshe led the development of a new type of stent for the treatment of hypertension at Vascular Dynamics. The stent is in advanced clinical trials with the potential to impact over one billion people. Moshe founded and led Asymmetric medical, where he invented the SmartFiber an asymmetric revolutionary fiber optic that redefined the use of fibers in the medical world. The SmartFiber was integrated in various products for the laparoscopy, orthopedic surgery and GYN including collaborations with Flex Inc. and TAG Medical. Moshe is also a veteran of the Israeli Air Force discharged as a Major and continues to be an active pilot.
Again, it depends on what price they got for the 1200 or so units they sold. At $20,000 or even $10,000 per unit there would likely be enough to take out or easily borrow $4 million for a new product in a spin off company. I am unfamiliar with the types of publication that may cover these types of devices, so as to maybe see a price in an advertisement or a number to call, though I doubt if they would give an IPIX investor much info, unless he/she had some deep pockets and was going to buy some units (Unlikely, as that would seem). As usual there seem to be more questions than hared facts.
More about the NeoLaser from a National Library of Medicine site for journal articles and studies. This is really quite successful stuff. I too am wondering why some of the inventors needed 4 million more. I am guessing that would have been relatively easy to pull from this relatively big operation. Unless the new equipment will augment the previous, successful equipment and go into a large, allied business. But I am just speculating.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9108407/
2022; 19(4): 695–700.
Published online 2022 Mar 28. doi: 10.7150/ijms.70916
PMCID: PMC9108407
PMID: 35582422
Efficacy and safety of endovenous laser ablation with the 1470 nm diode laser using a novel optical probe
Karsten Hartmann, MD,1,* Patrick Gholam, MD,2,* Carmen Dietrich, MD,2 and Christine Fink, MD2,?
Author information Article notes Copyright and License information Disclaimer
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ABSTRACT
Objectives: Outcome assessment of a novel optical fiber probe for the 1470 nm diode laser under real-world conditions.
Methods: Prospective clinical pilot study in 10 patients undergoing endovenous laser ablation with a follow-up period of 1 year. Primary endpoints were efficacy and safety. Secondary endpoints include, inter alia, quality of life and patient satisfaction.
Results: After a follow-up period of 1 year all treated vein segments were still occluded. Only mild and short-term side effects (hematoma, ecchymosis and hyperpigmentation) were observed. No intake of pain medication was needed and a quick return to normal activity was documented (0.9 days). Clinical hallmarks of the venous disease (VCSS) improved significantly (p= .003). All patients were very satisfied with the treatment and quality of life (AVVQ) was significantly improved after the procedure (p=.008).
Conclusions: The study demonstrates that the endoluminal treatment with the novel fiber probe is highly effective and safe.
Keywords: Varicose veins, EVLA, Laser ablation, Efficacy, Safety, Outcome
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INTRODUCTION
Endovenous laser ablation (EVLA) is a safe endothermal treatment option for incompetent varicose veins of the lower extremities. In EVLA, a diode laser fiber is inserted percutaneously into the varicose vein. Permanent vein occlusion is caused by laser-induced thermal damage of the endothelium followed by subsequent fibrosis 1,2,3. Since the first report on EVLA was published in 1999 a substantial further development of the technology took place 4. Treatment efficacy (i.e. the occlusion rate) and safety strongly depends on how the laser energy is dosed within the treated vein. The majority of the current established optical fiber probes emit the laser radiation radially onto the vein wall 5. The release of laser energy is typically confined to a well-defined narrow area of approximately 0.5 mm in length along the vein (Figure ?(Figure1A).1A). To treat a vein segment over its full length, it is therefore necessary to move the probe through the vein while the laser is activated 2,5. Endovenous energy distribution with subsequent heating of the vein wall should be as uniform as possible. On one hand, unintentional local underdosing of energy leads to a decreased occlusion rate; but on the other hand, an overdose of radiation is accompanied with an increased complication rate (i.e. venous puncture with bruising, damage to surrounding nerves). In this context, a larger, more even energy distribution of the laser radiation might be advantageous. Within this study we evaluated an innovative optical fiber probe with a wider emission profile. In contrast to previous probes the laser energy is emitted evenly over a larger area of approx. 4 mm, so that a uniform radiation is possible (Figure ?(Figure1B).1B). In this way a large-scale and more even irradiation of the vein wall can be achieved which might have an impact on the safety and efficacy of EVLA. Aim of this clinical study was the evaluation of the safety and efficacy of the new optical fiber probe under “real world” conditions in a prospective setting with a one year-follow-up.
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Object name is ijmsv19p0695g001.jpg
Figure 1
A Commonly used optical fiber probe with radial light emission profile with energy release in a well-defined narrow area of approximately 0.5 mm in length along the vein (Example shows “neoLaser CORONA 360 Fused Fiber”, manufacturer: Light Guide Optics International Ltd.) B The newly developed optical fiber probe has a much wider emission profile. In this way a large-scale and more even irradiation of the vein wall can be achieved. (Example shows “neoLaser CORONA Infinite Ring Fiber”, manufacturer: Light Guide Optics International Ltd. Image courtesy of Light Guide Optics Germany GmbH, Germany)
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METHODS
This clinical study was performed in a prospective setting in ten consecutive patients (with eleven insufficient great saphenous veins (GSV)) with a medical indication for elective thermal ablation. Written informed consent for the procedure was given by all patients. The study was conducted in accordance with the Declaration of Helsinki principles (2013) and applicable local government regulations and independent Ethics Committee policies and procedures (ethics approval number F-2019-122).
Study endpoints
The primary objective of this study was to assess the efficacy (occlusion rate) and safety (intraoperative and postoperative complications e.g. deep vein thrombosis, paresthesia) of the new optical fiber probe within a follow-up period of one year. Secondary objectives of this study include, inter alia, postoperative pain, absence from work and normal activity, disease-specific quality of life and patient satisfaction. In total, six study visits were performed. Patients were examined at the time of recruitment (Baseline Visit; V1), the day of EVLA (V2), within ten days after EVLA (V3), two months (V4), six months (V5) and one year (V6) postoperatively. All patients were examined clinically and by duplex ultrasound by an experienced phlebologist. Postoperative pain was assessed by means of the VAS score (visual analogue pain scale 6). Patients were asked to evaluate the pain on a scale of one (no pain) to ten (severe pain) within ten days after EVLA in four categories: the greatest pain since the last visit; currently experienced pain in the area of the operated limb; the current pressure pain; the most severe pressure pain since the last visit. Moreover, postoperative pain (in days), intake of pain medication and absence from work and normal activity (in days) was documented. Furthermore, each patient was required to evaluate satisfaction with the endoluminal treatment on a scale of one (very satisfied) to five (very unsatisfied) after two months, six months and one year. The disease severity and outcome of therapy for venous disease was assessed via validated Venous Clinical Severity Score (VCSS) 7. The VCSS facilitates features of venous disease that change with treatment and includes ten hallmarks of venous disease. Disease-specific quality of life was determined by means of the Aberdeen Varicose Vein Symptom Severity Score (AVVQ) which is a validated 13-question survey addressing all elements of varicose vein disease 8. Both questionnaires are scored from 0 (indicating no effect on the patient from varicose veins) to 100 (indicating severe effect).
Endovenous procedure
In all patients EVLA was performed with the novel market approved optical fiber probe “neoLaser CORONA Infinite Ring Fiber” (manufacturer: Light Guide Optics International Ltd.) suitable for the 1470 nm diode laser (“neoV1470”, manufacturer: neoLaser, Israel) according to the manufacturer's instructions. The laser fiber was introduced to the GSV at the distal point of insufficiency via a sheath followed by the positioning at the sapheno-femoral junction (SFJ) under sonographic control. The entire EVLA was performed under sonographic monitoring and tumescent local anesthesia. Laser energy was delivered at 10W. Additionally, foam sclerotherapy was performed after EVLA when insufficient tributaries were present which was determined by clinical examination and by duplex ultrasound. Taking into account possible contraindications thrombosis prophylaxis with low molecular weight heparins (40 mg s.c.) was given immediately after EVLA for one day and compression therapy with class II stockings was recommended for ten days.
Statistical analysis
Descriptive analyses were performed (frequency, mean, range). Non-parametric tests were applied to assess for statistical significance (Wilcoxon signed rank). p<0.05 was considered statistically significant. SPSS Version 25 (IBM, SPSS; Chicago, Illinois, USA) was used.
Patient and Public involvement
Patients or the public were not involved in the design, or conduct, or reporting, or dissemination plans of our research.
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RESULTS
Patients and GSV characteristics
Ten patients with eleven insufficient GSV (n=11) were recruited between January 2020 and May 2020. A reflux time of >0.5 seconds for GSV was used to diagnose the presence of reflux. Three (27.3%) of the patients' legs showed CEAP stage 2 with varicose veins (with a diameter of 3mm or more), five (45.5%) legs showed CEAP stage 3 with edema and three (27.3%) legs showed CEAP stage 4 with changes in skin and subcutaneous tissue secondary to chronic venous disorder. All patients showed a complete incompetence of the GSV. The reflux passed directly through the saphenofemoral junction (SFJ) into the GSV due to an incompetent terminal and preterminal valve. One leg (9.1%) showed Hach stage II with an insufficiency from the SFJ to a hand's breadth above the knee joint. The majorities of the GSV showed Hach stage III (90.9%) with an insufficiency starting from the SFJ to below the knee. Mean diameter of the GSV at the SFJ was 8 mm, mean diameter 3 cm below SFJ was 7.3 mm and mean diameter 15 cm below SFJ was 6.3 mm. Mean length of the treated GSV was 43.9 cm. The average LEED for GSV ablation was 69.75 J/cm. In 90.9% EVLA was combined with foam sclerotherapy in tributaries. Foam sclerotherapy was performed directly after EVLA. Mean dose of administered foam was 3,3 ml (min-max: 1-6 ml) (Table ?(Table11).
Table 1
Patients and GSV characteristics are depicted.
Patients (No.) 10
Legs (No.) 11
Age in years (mean; range) 53.2 (28-76)
Gender (male/female) 6/4
Height (cm) (mean; range) 172 (153-186)
Weight (kg) (mean; range) 74.9 (59-104)
Body side (left/right) 9/2
Hach stage (No. (%))
Hach II 1 (9.1%)
Hach III 10 (90.9%)
CEAP stage (No. (%))
C2 3 (27.3%)
C3 5 (45.5%)
C4 3 (27.3%)
GSV Diameter (mm) (mean; range)
SFJ 8 mm (5.2-10.9)
3 cm below SFJ 7.3 mm (5.3-11.1)
15 cm below SFJ 6.3 mm (5-9.7)
LEED (J/cm) (mean; range) 69.75 (49-95.6)
Length of the treated GSV (cm) (mean; range) 43.9 (21-59)
Combined therapy* (No. (%)) 10 (90.9%)
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CEAP: clinical, aetiological, anatomical and pathological; GSV: great saphenous vein; SFJ: sapheno-femoral junction, LEED: linear endovenous energy density; *Combined therapy = EVLA plus foam sclerotherapy in tributaries.
Efficacy and Safety
A duplex ultrasound was performed by an experienced phlebologist at six time points (before endovenous laser ablation (EVLA), at the day of the procedure, within ten days after EVLA, two months, six months and one year after EVLA. Additionally, a clinical examination was performed at each of the six time points. Intraoperatively no complications occurred. Within ten days after EVLA two hematomas and one ecchymosis were present which were dissolved until the next examination. Examination after two and six months showed a hyperpigmentation in one patient's leg in the treated area which was gone at the next follow-up visit. Deep vein thrombosis, pulmonary embolism, phlebitis, paresthesia or recurrent varicose veins were not seen in any of the patients. Sonography within ten days after EVLA showed an occlusion rate of 100%. After one year of follow-up all treated vein segments were still occluded (distal point of insufficiency until SFJ) in all patients (Table ?(Table22).
Table 2
Intra- and postoperative complications and occlusion rate
Complications (No.) V2 (EVLA) V3 (10 d)* V4 (2 m)* V5 (6 m)* V6 (1 yr)*
Hematoma 0 2 0 0 0
Ecchymosis 0 1 0 0 0
Hyperpigmentation 0 0 1 1 0
Deep vein thrombosis 0 0 0 0 0
Pulmonary embolism 0 0 0 0 0
Phlebitis 0 0 0 0 0
Paresthesia 0 0 0 0 0
Recurrent varicose veins 0 0 0 0 0
No complications (No.) 11 8 10 10 11
GSV occlusion (No.) 11 11 11 11 11
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*Follow-up visits were performed at the day of EVLA (V2), within 10 days after EVLA (V3), 2 months (V4), 6 months (V5) and 1 year (V6) postoperatively. GSV: great saphenous vein
Post-operative pain and absence from work
Data analysis showed that patients experienced only mild postoperative pain with an average duration of 0.9 days. None of the patients had to take pain medication after EVLA. The average number of absence from work and normal activity in days was 0.8 (Table ?(Table33).
Table 3
Post-operative pain and absence from work
Post-operative pain intensity within 10 days after EVLA (0-10) (mean±SD)
The greatest pain since the last visit 2.78 ±2.59
Currently experienced pain in the area of the operated limb 1.22 ±0.67
The most severe pressure pain since the last visit 3.33 ±2.78
The current pressure pain 1.89 ±1.05
Postoperative pain in days (mean; range) 0.9 (0-3)
Intake of pain medication in days (mean; range) 0.0 (0-0)
Absence from work and normal activity in days (mean; range) 0.8 (0-4)
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SD: standard deviation
Patient-reported outcome measures: response to therapy (VCSS), quality of life (AVVQ) and patient satisfaction
The VCSS questionnaire includes ten clinical hallmarks of venous disease (e.g. pain, edema, inflammation, number of active ulcers) that change with treatment and therefore reflects changes in response to therapy. Already ten days after EVLA the VCSS showed a significant improvement which continued to improve over time when correlated to the Baseline Visit (V1). The disease-specific quality of life (AVVQ) was significantly improved two months after EVLA. Furthermore, evaluation of patient satisfaction showed that all patients were very satisfied with the treatment (Table ?(Table4,4, Fig. ?Fig.22).
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Object name is ijmsv19p0695g002.jpg
Figure 2
Patient-reported therapy outcome (VCSS) and quality of life (AVVQ): Analysis of the VCSS questionnaire showed a significant improvement over time. The disease-specific quality of life (AVVQ) was significantly improved two months after EVLA. Absolute difference of each study visit correlated to the Baseline Visit (VCSS: mean 18.48 and AVVQ: mean 10.87) is depicted.
Table 4
Disease severity and outcome of therapy for venous disease (VCSS), disease-specific quality of life (AVVQ) and patient satisfaction
VCSS (0-100) (mean±SD) p-value*
V1 (Baseline) 18.48 (±10.99)
V3 (10 days) 10 (±3.94) .034
V4 (2 months) 4 (±4.66) .007
V5 (6 months) 2.73 (±5.12) .003
V6 (1 year) 0.91 (±1.56) .003
AVVQ (0-100) (mean±SD) p-value*
V1 (Baseline) 10.87 (±7.15)
V3 (10 days) 10.69 (±6.65) .906
V4 (2 months) 4.01 (±4.79) .025
V5 (6 months) 2.66 (±3.59) .012
V6 (1 year) 1.82 (±3.37) .008
Patient satisfaction (1-5) (mean; range)
V4 (2 months) 1 (1-1)
V5 (6 months) 1.1 (1-2)
V6 (1 year) 1 (1-1)
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VCSS: Venous Clinical Severity Score; AVVQ: Aberdeen Varicose Vein Symptom Severity Score; SD: standard deviation; *p-values: V3, V4, V5, V6 were correlated to V1.
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DISCUSSION
Over the last decades tremendous improvements could be observed in the treatment of varicose veins. In endovenous laser ablation (EVLA) permanent vein occlusion is caused by laser-induced thermal damage of the endothelium followed by subsequent fibrosis 1-3. Constantly new technologies and products are developed and gain market approval 1-3. Currently the 1470nm diode laser with the radial fiber probe is widely used for thermal ablation of the GSV which was shown to be highly effective and safe 5. Nevertheless, a continuous improvement of the technology should be targeted with an even higher occlusion rate and increased safety.
Within this prospective clinical study an innovative optical fiber probe was evaluated for the first time under “real world” conditions. The assessed fiber probe is characterized by a larger and more even energy distribution of the laser radiation. In comparison to the radial fiber probe the laser energy is emitted evenly over a larger area which allows for a more uniform radiation. In this study a total of eleven insufficient GSV were occluded and patients were regularly followed up over a period of one year.
Primary endpoints of this study were to assess the efficacy and safety of the fiber probe. Efficacy reflected by the occlusion rate was 100% within ten days after EVLA. After one year of follow-up all treated vein segments were still occluded. Furthermore, data analysis showed no intraoperative complications. Postoperatively, only mild side effects were observed (two hematomas, one ecchymosis and one hyperpigmentation which were dissolved until the next visit). Moderate or severe adverse events (e.g. deep vein thrombosis, superficial phlebitis and paresthesia) were not seen in the study population.
Secondary study objectives included post-operative pain and absence from work and patient satisfaction. On average patients experienced only mild postoperative pain with a short mean duration of 0.9 days. None of the patients had to take pain medication after EVLA. Patients were able to return quickly to work and normal activity after a mean duration of sick leave of 0.8 days.
Since the inclusion of patients' preferences and needs is a fundamental requirement for a successful physician-patient relationship, the assessment of patient-reported outcome measures in clinical trials is essential. Therefore, this study evaluated as further secondary study objectives the patient-reported outcome measures patient satisfaction, the disease severity and outcome of therapy for venous disease (by means of the VCSS questionnaire) and the disease-specific quality of life (by means of the AVVQ questionnaire). Evaluation of patient satisfaction showed that all patients were very satisfied with the treatment two months, six months and one year after EVLA. The VCSS questionnaire reflects changes in response to EVLA and showed a significant improvement right after the procedure. Clinical hallmarks of the venous disease further improved significantly over the follow-up period of one year. Also the disease-specific quality of life was significantly improved two months after EVLA.
Altogether, our study reveals several limitations. The study findings need to be interpreted in the context of the study design and the patient population. Since this is a pilot study the relatively small sample size might limit the generalizability of the results. Therefore, the next step is to evaluate the novel fiber probe in a randomized controlled setting in comparison to the radial fiber probe with a bigger sample size for more representative results. Secondly, a longer follow-up period might provide further important long-term information concerning the occlusion rate. Strengths of the study are that the patients were observed in a prospective setting under real-life clinical conditions. Additionally, essential patient related outcome measures (e.g. quality of life and response to therapy) were assessed by validated scores.
In conclusion this study demonstrates that the 1470nm diode laser with the novel fiber probe is a highly effective technical innovation with an occlusion rate of 100% after a follow-up of one year. The data demonstrates the excellent safety with only few and mild complications.
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FUNDING
This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
Author Contribution
Conception and design: KH, CF; Analysis and interpretation: KH, PG, CF; Data collection: KH, CF, CD; Writing the article: KH, PG, CF; Critical revision of the article: KH, PG, CD, CF; Final approval of the article: KH, PG, CD, CF; Overall responsibility: KH, CF.
Ethics
Reviewed and approved by the ethic committee of Landesärztkammer Baden-Württemberg (Approval number F-2019-122).
Data sharing statement
The data that support the findings of this study are available from the corresponding author, [CF], upon reasonable request.
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ABBREVIATIONS
EVLA Endovenous Laser Ablation
GSV Great Saphenous Vein
SFJ Sapheno-femoral junction
VAS visual analogue pain
VCSS Venous Clinical Severity Score
AVVQ Aberdeen Varicose Vein Symptom Severity Score
ICH-GCP International Conference on Harmonization-Good Clinical Practice
CEAP Clinical, aetiological, anatomical and pathological
SD Standard Deviation
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REFERENCES
1. NICE Guidance. www.nice.org.uk/guidance/cg168.
2. Teter KA, Kabnick LS, Sadek M. Endovenous laser ablation: A comprehensive review. Phlebology. 2020;35(9):656–662. doi: 10.1177/0268355520937619. Epub 2020 Jul 6. PMID: 32631172. [PubMed] [Google Scholar]
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Good point, LR.
I am still wracking my brain re the federal site (I think) that is valuable re reviewing newly approved, medical equipment uses.
Another cut on the BeaMed laser. The FDA action means that the laser can be produced and sold and used because it is substantially similar to some other approved laser device(s) on the market. It still means that the devices need to be manufactured, sold and then advertised in the magazines and research journals for specific uses, so that they can be purchased and then used in hospitals, emergency centers or doctors offices. End users need to know about the device, its track record, cost and effectiveness before it can be sold in any great numbers. It has been mentioned on the board that we have no idea of the price, so there is still lots to know. I feel this was a good purchase, but we are a year or two away from any substantial sales, unless the producers have been busy in ways we are not aware. We can hope. I used to have a contract with a company that made devices that were designed to be similar to those already having been approved. Lots of that goes on with 510s and it is not sleazy or illegal. Just is. If we want to know more we need to review the magazines and journals for similar products to see about prices, uses. I'm going to do a bit of searching myself, but I have little knowledge regarding where to start. I did the contract a few years back, so it is a bit misty to me now. There is a federal site you can look up products on, forget the tag, but it shouldn't be that hard to find. Just cleared my notes out a few month ago, bad moves I think.
Full of good cheer for the holiday season?
You got me by three years. Love your optimism. But at Thanksgiving I will remain mum about IPIX as I convinced some others to buy at a buck. Humble pie and Turkey are not a good mix. I really don't have a ghost regarding the future of this albatross.
Last week an acquaintance had a topical skin infection after having a catheter removed. He treated himself with antibiotics Bacitracin and later with Neosporin, two otc ointments, but neither worked. He went to a doc and had Mupirocin prescribed, a much stronger compound, and it appears to be working. Wouldn't you think Brilacidin would make a fine topical if it were as potent with bacteria, viral agents and even fungi as we have been led to believe. A few, large primary care practices could produce lots of patients for an FDA study. How hard could it be? We constantly hear the conflicting themes of how difficult it is to make money on antibiotics and the conflicting theme of the worldwide need for more antibiotics because of growing overuse problems. Again, where is Leo on this? A single ointment with all this potential, or does Leo feel it doesn't have the legs, as they say. Or is he a lousy negotiator, or whatever. Each day the patents grow older and no progress. I'm not sure how many docs remain on the board, or others with special skills in the FDA test cycle to observe that I am FOS, or not.
Really, guys, are we ever going to make any money here? And I say that as a soon to be 7 year holder. I was even tempted to get a hundred thousand more shares for a few thousand, but thankfully I didn't.
Good point, LR.
"The Phase 2 hasn't started"
You're right, I stand corrected.
"It would require the patience of a Saint to hold shares through a run from $.04 to $.50."
Yes it would, and I'm no saint. If I remained rationale I'd sell in pieces as it rose. If it rose, and if I remained rationale.
I'm projecting that the AlfaSigma test of B for IBD will be completed by late 2022 but more likely mid 2023, or even later. There is no recent info on the status of this test, of which I am aware. Why do you feel this is years away?
Still hoping for an AlfaSigma success and IPIX has nothing to do but wait a few more months, to know, one way or another. I know some posters seem to have lost any real hopes on this front. If B is worth anything its overall value as an IBD med will jump like crazy, IMO. Pps would rise regardless of actions by Leo and friends. I'd start bailing at .50, which would be easily reached and surpassed, given a clear FDA3 success. Apologies for the pie in the sky stuff, but hey, could happen. Ok, maybe .50 is more than a bit on the high side, but who knows.
Thanks for responding, I value your posts.
The thing that has always bothered me is the fact that oral mucositis (OM) affects many more cancer patients than just head and neck cancer patients. It is hard to nail down any estimates, at least I've been unable to do so after several searches, but they have to be huge. My brother had chemo for intestinal cancer and he had severe OM. We'd go in for his therapy and see scads of similar patients having trouble eating or swallowing after the chemo. With this potentially huge marked it has always surprised me that Leo has not made any sort of deal so that an FDA 3 could be conducted. The traditional question of either a lack of BP interest or bad negotiating on Leo's part remains. I know the FDA 2 numbers were not stellar, but in such a large market with such a lack of truly effective therapies, you'd think we'd see more progress. Any progress?
FWIW Just saw lots of new posts by Alfasigma on Linkedin. If B tests out well in the next few months I really do believe that AS will buy/license the rest of the IBD-related uses for Brilacidin, maybe the whole pie, OM and all. Just idle speculation based on nothing but my hunch work.
PJ, I've always thought that IPIX did (paid for) a series of invitro and invivo studies, small ones no doubt, to further assess the utility/safety of Kevetrin. I know it seemed to show potential on the small FDA 1, but over the years it had to have been followed up on. You don't just give up on a potential blockbuster, unless the preponderance of evidence says it isn't. Just my guess. Leo is greedy and hugely self-interested, but not stupid, imo. And the follow-up FDA 2,3 would take $50-100 million, more or less, a few years or more, for sure, and no one with deeper pockets seems to be pitching any offers.
"It's not any government's job to pick winners among private companies. That's supposed to be the function of the capital markets, including stock markets, venture capital and venture debt.)"
While I generally agree with you, there are some modest exceptions. HHS/ASPR/BARDA on occasion and even the NIH can select a small winner, so to speak, ignoring the offerings of the big boys. But, as we see, that rarely happens and to date has not happened here. I know I am quibbling, but sometimes that's all we can really do here. Appreciate your posts (Ok, not all the time!).
What bothers me about all the impressive federal and GMU invitro testing of Brilacidin is that it does not take that much time, and yet we know nothing. We hear nothing. And that can not be a good sign. Articles in the professional journals, promised, but where are the galleys? Quiet but for the soft whoosh of dropping prices.
And the annual flu. Sounds like a party none of us wants to attend, but that all of us will.
I was hoping you wouldn't ask, as I can not find them. They were a couple of folks who used to work for HHS/BARDA, as I did, and now for the life of me I can't find them. It was before the post covid "pps crash" so I am betting they bailed as winners or losers, not sure which. But just speculation. I'll keep looking.
Every so often I get on Linkedin, where some IPIX investors have a presence, as well as the company itself, but so far nothing regarding IPIX that I have found.
Unopenable. But cruising around I saw this re AS:
#Alfasigma reached an agreement for the acquisition of SOFAR S.p.A., an Italian company focused on the development, manufacturing and distribution of drugs, food supplements and medical devices.
This acquisition enables Alfasigma to enrich its product portfolio, especially in the gastroenterology area, where SOFAR holds top brands such as Enterolactis, Pentacol, Gerdoff and to acquire Cistiflux and Siler as well, leading brands in their respective therapeutic areas.
SOFAR has over 300 employees, a production plant in the Milan province and a R&D lab in Bergamo. Last year’s turnover was 113 million Euro with a double-digit growth rate.
Wouldn't it be nice IF------
Doesn't really matter much considering that there really is no public health system in the US. What we have is vast, understaffed, hesitant and pretty useless in the face of threats like HIV/AIDS, covid, monkey pox. covid variants, etc. As a nation we are in for it, as they say. By November it is likely we will face resurgent covid variants and a rampaging monkey pox. And the public health system will be more focused on using the term "men who have sex with men,." than "gay men" as opposed to contact tracing, quarantine issues, self and institutional testing, massive amounts of vaccine, etc..