Curated research to understand technology benefits, comparisons, and limitations, prioritizing studies that identify devices or brands in our portfolio.
Models in the portfolio2024 · Jin L et al.
LHP vs rubber band ligation
Laser hemorrhoidoplasty vs. rubber band ligation: a randomized trial comparing 2 mini-invasive treatment for grade II hemorrhoids
BMC surgery
Randomised trial · 70 patients · Grade II haemorrhoids · Single centre
Findings: LHP resulted in less pain, bleeding, and discomfort during the first two weeks, with an earlier return to normal activities.
Points to consider: Recurrence at one year did not differ significantly. These grade II results do not establish superiority for all types of haemorrhoids.
Device & relevance: LEONARDO DUAL 45 (biolitec), 980 + 1470 nm, explicitly named in the methods.
DOI: 10.1186/s12893-024-02425-z
Brands in our portfolio2023 · Tantrakul V et al.
CPAP in high-risk pregnancy with OSA
Treatment of obstructive sleep apnea in high risk pregnancy: a multicenter randomized controlled trial
Respiratory research
Open-label randomised trial · Three hospitals · 310 participants in the primary analysis
Findings: Diastolic blood pressure decreased by an average of 2.2 mmHg. Preeclampsia occurred in 13.1% of the CPAP group vs 22.3% with usual care.
Points to consider: 96.5% were recruited in the first trimester; this was not a trial of starting CPAP specifically in trimester III. Mean adherence was 2.5 hours/night. Findings apply to the high-risk OSA population studied.
Device & relevance: Philips Respironics REMstar Auto M / DreamStation named in the methods; the currently offered model needs to be matched.
DOI: 10.1186/s12931-023-02445-y
Procedure evidence2020 · Poskus T et al.
LHP, mucopexy, and excisional haemorrhoidectomy
Results of the double-blind randomized controlled trial comparing laser hemorrhoidoplasty with sutured mucopexy and excisional hemorrhoidectomy
International journal of colorectal disease
Randomised trial · 121 patients · Grade II–III haemorrhoids · Single centre
Findings: LHP was less painful than excision. Return to activity: 15 days after LHP, 22 after mucopexy, and 30 after excision.
Points to consider: Recurrence requiring treatment at one year: LHP 10%, mucopexy 22%, excision 0%. Recovery comfort should be considered alongside durability of results.
Device & relevance: 1470 nm diode laser; this summary does not assume equivalence across all biolitec models.
DOI: 10.1007/s00384-019-03460-6
Procedure evidence2025 · Ng CPY et al.
TULA for recurrent NMIBC: long-term outcomes
Long-term outcome of transurethral laser ablation for recurrent non-muscle invasive bladder cancer: An EORTC risk-matched study
BJUI compass
Retrospective cohort · 319 patients · 1,186 procedures · Median follow-up 4.4 years
Findings: The study reported a 4% complication rate in a predominantly older population with comorbidities. Progression and recurrence risks were assessed by EORTC group.
Points to consider: Five-year recurrence remained high. A single-center study without randomized comparison; it does not establish TULA as a replacement for TURBT in all patients. One author received biolitec educational funding.
Device & relevance: Dual 1470/980 nm diode laser; no model name stated in the methods reviewed.
DOI: 10.1002/bco2.70052
Procedure evidence2017 · Brouwer PA et al.
PLDD vs microdiscectomy: two-year evaluation
Percutaneous laser disc decompression versus conventional microdiscectomy for patients with sciatica: Two-year results of a randomised controlled trial
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
Multicentre randomised trial · Surgical candidates with contained disc herniation
Findings: A PLDD strategy with surgery when needed had non-inferior two-year outcomes compared with a microdiscectomy strategy. 48% of the PLDD group avoided surgery.
Points to consider: Reintervention was higher after PLDD: 52% versus 21%. Results apply to selected patients with herniation occupying less than one-third of the spinal canal.
Device & relevance: PLDD procedure research; a match to current biolitec device models has not been verified.
DOI: 10.1177/1591019917699981
General clinical evidence2020 · Garza JR et al.
SVF in knee osteoarthritis: placebo-controlled trial
Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial
The American journal of sports medicine
Double-blind randomised trial · 39 patients · Two SVF doses vs placebo
Findings: WOMAC symptom scores improved more in the SVF groups than with placebo through 12 months.
Points to consider: Small sample; MRI showed no change in cartilage thickness. Read alongside the larger MILES trial, which used different methods and comparators.
Device & relevance: The processing method in this study has not been matched to SONICSTEM; it is not direct evidence for the Cellabsys device.
DOI: 10.1177/0363546519899923
General clinical evidence2023 · Mautner et al.
MILES: cell therapy vs corticosteroids for the knee
Cell-based versus corticosteroid injections for knee pain in osteoarthritis: a randomized phase 3 trial
Nature Medicine
Multicentre randomised trial · 480 participants · Grade II–IV knee osteoarthritis
Findings: At one year, SVF, bone marrow aspirate concentrate, and umbilical cord tissue-derived cells were not superior to corticosteroids for the primary pain outcome.
Points to consider: No significant change in MRI osteoarthritis scores was found. These findings cannot be generalized to all cell preparations or processing methods.
Device & relevance: General cell therapy evidence; not a SONICSTEM clinical trial.
DOI: 10.1038/s41591-023-02632-w
General clinical evidence2023 · Facco FL et al.
PAP in pregnancy: inconsistent findings
A trial of positive airway pressure for the treatment of sleep apnea in pregnancy
American journal of obstetrics & gynecology MFM
Randomised trial · 89 participants with OSA and obesity · Assessment at 28–31 weeks
Findings: There was no significant difference in the primary composite cardiometabolic risk outcome between treatment and control groups.
Points to consider: Treatment adherence was low; the control design changed between phases. Read this study alongside the Tantrakul trial, rather than selecting only positive findings.
Device & relevance: Brand/model match has not been verified.
DOI: 10.1016/j.ajogmf.2022.100840
General clinical evidence2016 · McEvoy RD et al.
CPAP, OSA symptoms, and cardiovascular outcomes
CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea
The New England journal of medicine
SAVE · Randomised trial · 2,717 adults with OSA and cardiovascular disease
Findings: CPAP improved snoring, daytime sleepiness, mood, and health-related quality of life.
Points to consider: Major cardiovascular events were not reduced in this population over an average 3.7 years; average use was 3.3 hours/night.
Device & relevance: CPAP evidence in OSA; the identity of the model offered must be assessed separately from the study findings.
DOI: 10.1056/nejmoa1606599
Brand / device family2023 · Barba M et al.
LaEvita / LEONARDO: an early GSM study
Efficacy of a Diode Vaginal Laser in the Treatment of the Genitourinary Syndrome of Menopause
Bioengineering 10(10):1158
Prospective · 26 patients · No comparison group · Assessment one month after three monthly sessions
Findings: 19 of 26 patients (73.1%) reported improvement on PGI-I. Vaginal health and symptom scores improved; no adverse events were reported during this observation.
Points to consider: Small sample, no control or sham group, and short follow-up. It does not establish superiority to standard therapy, benefit for SUI, or long-term safety.
Device & relevance: LEONARDO Dual diode laser, Biolitec Italia, 980 + 1470 nm, named in the methods; the power variant needs to be matched.
DOI: 10.3390/bioengineering10101158
Brand / device family2024 · Vitale SG et al.
LEONARDO for GSM: follow-up to six months
Efficacy and Safety of Non-Ablative Dual Wavelength Diode Laser Therapy for Genitourinary Syndrome of Menopause: A Single-Center Prospective Study
Advances in Therapy 41:4617–4627
Prospective pilot study · 22 postmenopausal women · Single centre · Three sessions · No control group
Findings: At six months, VHIS increased from 12 to 19.27. Vaginal dryness scores fell from 7.72 to 3.72; burning and dyspareunia also improved.
Points to consider: A small study without a comparator. Before–after results cannot separate intervention effects from other factors or establish superiority or long-term safety.
Device & relevance: The abstract names a LEONARDO dual-wavelength diode laser. The offered variant and configuration must be matched to the full publication.
DOI: 10.1007/s12325-024-03004-7
Procedure evidence · Other devices2021 · Bizjak-Ogrinc U, Senčar S
Laser labiaplasty: satisfaction and complications in a series of 80 patients
Sutureless Laser Labiaplasty of Labia Minora
Sexual Medicine 9:100406
Retrospective · 80 patients · No control group · Satisfaction assessed around day 60
Findings: 76 patients were very satisfied and four were satisfied. Seven wound infections, one bleeding event, and one haematoma were recorded.
Points to consider: Retrospective bias, no randomised comparator, and limited follow-up. This does not establish that laser is superior to other techniques.
Device & relevance: Er:YAG 2940 nm SP Dynamis (Fotona), not biolitec. Included as procedural context; it does not establish indications or outcomes for labiaplasty with LEONARDO.
DOI: 10.1016/j.esxm.2021.100406
No matching studies. Try another term or select all journals.
