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HYPERLIGHT

IN WOUND HEALING

• • • •

PATENTED TECHNOLOGY CLINICALLY TESTED, PROVEN & CERTIFIED SWISS-MADE REGISTERED AS A MEDICAL DEVICE UNDER: EU (93/42/EEC)

HYPERLIGHT THERAPY SYSTEM Swiss-made BIOPTRON® Hyperlight therapy is a non-invasive, drug-free treatment modality that stimulates the body’s natural healing processes, resulting in minimal heat generation, no skin damage, and no reported side effects. This therapy has gained acceptance as a valuable approach for disease prevention, treatment, and recovery.

BIOPTRON® HYPERLIGHT THERAPY IN WOUND CARE Clinical trials in the field of regenerative medicine have consistently demonstrated the remarkable healing power of BIOPTRON® Hyperlight therapy. These studies have highlighted BIOPTRON®’s ability to significantly accelerate the closure of diverse wound types. By stimulating cellular activity and enhancing microcirculation, BIOPTRON® devices promote the body’s natural regenerative processes, leading to faster and more effective wound healing. This evidence-based approach underscores BIOPTRON®’s efficacy in supporting tissue repair and recovery, offering patients a non-invasive and drug-free solution for accelerated wound closure. BIOPTRON® is medically certified to treat: • Venous leg ulcers (stasis ulcers) (Jankovic 2005; Medenica & Lens 2003; Jankovic et al., 2010; Aragona et al., 2017; Waked et al., 2021)

HOW BIOPTRON® HYPERLIGHT ACCELERATES THE REGENERATION AND PROMOTES WOUND HEALING (See scientific reference list)

Connective tissue

Secretion of collagen matrix

EPIDERMIS

Migration to wound

DERMIS

FIBROBLAST BIOPTRON® Hyperlight therapy promotes the migration of new-formed fibrolasts to the wound, accelerating the healing process. BIOPTRON® Hyperlight increases fibroblast proliferation and migration:

• Burns (Monstrey 2002; Mowafy et al., 2021, 2022; Abdel-Mageed 2015; Abd El-Rashid NA 2018, 2019)

Fibroblasts are the driving force of wound healing, through their ability to synthesize collagen, form granulation tissue, and remodel the extracellular matrix. BIOPTRON® Hyperlight increases the proliferation of newly formed fibroblasts, accelerating closure and facilitating tissue regeneration by forming essential granulation tissue.

• Grafting (Monstrey 2002)

BIOPTRON® Hyperlight helps stimulate collagen production:

(Al-Kader et al., 2015; Bialozyt et al., 2018; Durovic et al., 2008; Iordanou et al., 2002; Aragona et al., 2017; Waked et al., 2021; • Pressure ulcers Chen et al., 2023; Makovskaya 2023)

• Foot ulcers (El-Deen 2014; Mohamed et al., 2019; Taha et al., 2022)

• Post-surgery wounds • Injury

(Simic et al., 1999, 2001 (1-2); Colic et al., 2004; Kymplova et al., 2003; Ahmed et al., 2020; Monstrey et al., 2002; Mohamed et al., 2016; Bahrami et al., 2023; Mowafy et al.,2016)

(Abdou et al., 2019; Rutterman et al., 2017; Nardi et al., 2021; Abd-Elhamed et al., 2022; El Sayed et al.,2021)

BIOPTRON® Hyperlight aids the production of endogenous collagen, providing the structural framework and scaffolding necessary for tissue repair. Collagen deposition strengthens the wound, providing tensile strength and preventing dehiscence (wound reopening). BIOPTRON® Hyperlight avoids hyperscarification and keloids: By using BIOPTRON® Hyperlight therapy, collagen is produced in a coordinated sequence during wound healing, ensuring proper tissue structuring and function. BIOPTRON® Hyperlight therapy contributes to scar maturation and improved tissue strength, minimizing scarring and developing smoother, more discrete and flexible scar tissue. BIOPTRON® Hyperlight improves microcirculation:

The absence of side efects makes BIOPTRON® Hyperlight suitable for pediatrics, making it safe for use on for newborns and children.

Impaired microcirculation can significantly delay wound closure and increase the risk of complications. BIOPTRON® Hyperlight increases the blood flow in capillaries, creating an optimal environment for wound healing by ensuring adequate oxygen and nutrient delivery, waste removal, immune response, and tissue regeneration. BIOPTRON® Hyperlight therapy supplies the newly formed cells with all they need to accelerate the regenerative process.

BIOPTRON® Hyperlight helps the body to fight against external pathogens: Delayed wound healing, increased scarring, and the development of chronic wounds are potential complications of infection. BIOPTRON® Hyperlight reinforces the immune system, helping to fight against external pathogens. Regular use of BIOPTRON® Hyperlight prevents the development of bacterial infection that impairs wound closure and tissue regeneration. BIOPTRON® Hyperlight diminishes inflammation: Inflammation is a crucial initial phase of wound healing, serving to clear debris and pathogens while signaling the recruitment of specific immune cells. However, excessive or prolonged inflammation can impede healing, leading to tissue damage and delayed wound closure. BIOPTRON® Hyperlight decreases the production of pro-inflammatory cytokines as IL-6 and TNF-α, reducing locally the inflammation of affected epithelium. BIOPTRON® Hyperlight stimulates pain relief: Constant and intolerable pain is disabling and devastating for the patients with chronic wounds. Pain impairs wound healing and slows down patient’s recovery. BIOPTRON® Hyperlight therapy helps to mitigate excessive inflammation, a key contributor to wound pain and delayed healing. BIOPTRON® Hyperlight also diminishes the stimulation of nociceptors (pain receptors). This dual action, targeting both inflammation and pain signaling pathways, contributes to BIOPTRON®’s efficacy in providing significant pain relief during the whole wound healing processes. CROSS-SECTION OF HEALING PROCESSES IN A SKIN WOUND 1. Increased microcirculation and angiogenesis

«SCAB»

EPIDERMIS DERMIS

3 Cytokines Fibroblast

Macrophages secreting cytokines. Blood vessels

Area of tissue repair

2. M igration of macrophages to damaged area. Secretion of cytokines and growth factors 3. Fibroblast proliferation and migration

CHRONIC WOUNDS (ULCERS, DECUBITUS, STASIS ULCERS) Chronic wounds have a significant negative impact on patients, due to persistent pain, reduced mobility, social isolation, and diminished quality of life. Hospitals face increased burdens due to prolonged patient stays, frequent readmissions, and the need for specialized wound care resources. BIOPTRON® Hyperlight therapy offers a multifaceted approach to addressing the challenges of chronic wounds. Its combined effects on several cellular mechanisms (see above) help to trigger stagnant healing processes, reduce pain, and promote the gradual closure of chronic wounds, ultimately improving patient quality of life. Several clinical trials have established the benefits of BIOPTRON® Hyperlight therapy for different types of chronic ulcers. These trials have consistently shown that BIOPTRON® treatment leads to a significant reduction in the wound size, calculated through the area and volume of the ulcer. Patients with Wagner grade 1 or 2 diabetic foot ulcers were divided in 2 groups: 1) BIOPTRON® Hyperlight therapy (12 minutes, 3 times per week, plus standard wound care) and 2) the control group under standard wound care alone over 2 months. The BIOPTRON® group showed a significantly greater reduction in ulcer size compared to the control group (*p < 0.001). Additionally, the BIOPTRON® group had a significantly higher rate of negative ulcer microbial cultures (60% vs. 15%, p = 0.02) after 8 weeks.

Ulcer surface 3 2.5 2

25.1% * 1.67

1.63

1.5

0.96

* 1.25

0.5 0

41.1%

Ulcer volume

Before After treatment

2 1.8

Ulcer volume (cm3)

Damaged tissues are very often characterized by poor and deficient blood supply, which could slow down and delay the recovery. BIOPTRON® Hyperlight promotes angiogenesis, creating new capillaries. The increased number and length of capillaries contribute to healthy tissue regeneration and shortened recovery time.

Ulcer surface area (cm2)

BIOPTRON® Hyperlight promotes angiogenesis:

Before After treatment

Healing of an ulcer in BIOPTRON® group

1.6 1.4 1.2 1 0.8 0.6 0.4 0.2 0

31.8%

56.2% *

* 0.64

BIOPTRON® group, after

0.66 0.45

0.28

BIOPTRON® group, before

Control group, before Control group, after

Before After Before After treatment treatment

Healing of an ulcer in control group

4. Collagen synthesis from fibroblasts 5. R einforced immune system and antimicrobicidal action

Figure 1. Changes in ulcer parameters in patients treated (n=20) and not treated (n=20) with BIOPTRON® Hyperlight devices (*p<0.001 control vs Bioptron group, and before vs post treatment within the same group). (Taha et al., 2022)

BIOPTRON® Hyperlight therapy reduced the surface area of stage 2 and 3 bedsores by at least 30%, with some ulcers fully healed in just 10 treatments (5 days).

BURNS

Stage 4 bedsores showed a minimum 30% reduction after 15 treatments.(Bialozyt et al., 2018)

BIOPTRON® Hyperlight therapy has emerged as a valuable adjunct in the management of burn injuries, offering a non-invasive approach to accelerate healing and alleviate associated pain. Studies have demonstrated the positive impact of BIOPTRON® Hyperlight on wound care, pain reduction, and the prevention of complications, making it a compelling tool for clinicians seeking to optimize patient outcomes. Given the significant benefits in minimizing scarring, shortening healing times, and decreasing pain, integrating BIOPTRON® Hyperlight therapy into standard burn care protocols offers an opportunity to treat wounds more effectively.

Upon admission, the patient presented with a deep, thirddegree pressure ulcer on the right heel (A). Following 10 phototherapy sessions, a A B C D significant reduction in both surface area and depth was observed (B). Complete healing was achieved after 22 sessions with BIOPTRON® Hyperlight therapy (C, D) .

Patients with partial thickness thermal burn were randomly assigned to 2 groups, receiving either BIOPTRON® Hyperlight therapy or low-level laser therapy (LLLT), alongside traditional burn care, 3 times weekly for 4 weeks. Both therapies significantly reduced bacterial colony counts and wound surface area (*p < 0.001). However, BIOPTRON® Hyperlight therapy demonstrated superior efficacy, achieving a 38.63% reduction in colony count and a 55.1% reduction in wound surface area, compared to 15.6% and 37.92% with LLLT. The findings indicate that the use of BIOPTRON® Hyperlight therapy accelerates the healing of thermal burn wounds.

Wound surface area

A deep, necrotic heel decubitus ulcer, which had worsened over 6 weeks, was treated daily with 5 minutes of BIOPTRON® therapy followed by standard cleaning. Within days, fibrin reduction and improved ulcer margins were observed. Within 10 days, wound healing was evident, and the ulcer significantly decreased in size. The ulcer completely healed in approximately 2 months (Korian nurse home, France, 2018).

Burn surface area (cm2)

9 8

55.1% *

7 6

Day 16

Day 35

Day 43

Day 67

A large, chronic bedsore on the buttocks, present for approximately 3 years, was treated with 12-minute BIOPTRON® therapy per day, 5 days a week, for 1 month. The treatment resulted in evident progressive healing, including a reduction in the ulcer area and depth, as well as decreased inflammation in the surrounding tissue. (Peers Village Retirement Home, Fishhook, (Cape Town, South Africa)).

Day 0

Day 8

Day 14

Day 21

4 3 2 1

Before

Day 12

37.92%

Day 2

After

Bacterial colony quantification 18

colony count (x 1010)

Third-degree pressure ulcer in the greater trochanter area (A). After 15 phototherapy sessions, improvement was observed (B). Significant healing progress was achieved after 30 sessions with BIOPTRON® Hyperlight therapy (C).

38.63%

15.6%

BIOPTRON® group, before

BIOPTRON® group, after

10 8 6

Control group, before

4 2 0

Before

After

Before

After

Before

After

Control group, after

Figure 2. Both BIOPTRON® and LLLT therapies reduced burn wound surface area and bacterial colony counts. However, BIOPTRON® significantly improved wound closure compared to LLLT (*p<0.001), and demonstrated a double reduction in bacterial counts (Mowafy et al., 2022) (24).

Treatment with BIOPTRON® Hyperlight over 2 weeks resulted in positive healing progression for a young girl with cooking plate burns. The therapy, administered at 10-minute sessions, 2 to 3 times daily in the first week and once daily in the second, led to rapid skin regeneration and a very good recovery (Hospital in Romania, 2018)

Day 28

2 weeks

POST-SURGERY SCARS Post-surgical wounds can present a range of complications that significantly impact patient recovery and well-being. Beyond the immediate discomfort of pain and swelling, patients may experience delayed healing, increasing the risk of infection and prolonging hospital stays. Wound dehiscence, or the reopening of the surgical incision, can lead to further complications and necessitate additional interventions. Scarring, both esthetically and functionally, can cause long-term discomfort and limit mobility. Effective post-surgical wound management is therefore crucial to minimize these issues and promote optimal healing. This study evaluated the impact of BIOPTRON® Hyperlight therapy on pain and fibrous scarring after mammoplasty. BIOPTRON® group received BIOPTRON® Hyperlight therapy plus traditional physical therapy, and the control group received traditional physical therapy alone. BIOPTRON® Hyperlight was administered daily for 10 minutes over 6 months. Pain (Visual Analogue Scale) and scar thickness (ultrasonography) were measured before and after treatment. Patients treated with BIOPTRON® demonstrated highly significant reductions in both pain and scar thickness. BIOPTRON® treatment resulted in a 78% pain reduction, compared to no change in the control group. Ultrasonographic measurements showed an 84% decrease in post-mammoplasty scarring tissue in the BIOPTRON® group (*p<0.05).

Visual Analogue scale (VAS 0-10)

Pain

78%

BIOPTRON® group, before

8 6

BIOPTRON® group, after

Control group, before

Control group, after

Before

After

Before

Fibrous scarring (cm)

84% *

BIOSTIMULATIVE EFFECTS OF BIOPTRON® HYPERLIGHT THERAPY Thanks to its multiple biostimulative effects, BIOPTRON® Hyperlight therapy is effective for a long list of conditions. (See scientific reference list)

• Accelerates healing process • Stimulates release of growth factors • Improves micro-circulation and improves local blood supply

• Diminishes the risk of infection by reinforcing immune system BIOPTRON group, before

• Increases the production of anti-inflammatory cytokines and reduces the release of pro-inflammatory cytokines

BIOPTRON® group, after

• Relieves the pain

1.5 1

• Reduces the release of chemical messengers that stimulate nociceptors

Control group, before 0.5

Control group, after

Before

After

Before

After

Figure 3. VAS and ultrasonographic scarring changes in group control and group treated with BIOPTRON® Hyperlight therapy (*p< 0.05) (Mowafy et al., 2016)

After blepharoplasty, the left side of the face—treated with BIOPTRON® Hyperlight therapy—showed significantly less swelling and fewer hematomas, as well as improved skin quality, compared to the untreated face side. Similar results were found after facial lifting.

• Triggers regenerative cellular mechanisms

After

Ultrasonography 2.5

BIOPTRON® Hyperlight therapy is the perfect ally after surgical esthetic procedures, optimizing the recovery period.

In each pair of images, the left photo shows one side of the face treated with BIOPTRON® for 5 and 7 days respectively (Colic et al., 2004)

BIOPTRON® Hyperlight therapy reduces pain and promotes skin recovery after esthetic surgery by stimulating microcirculation, reducing inflammation, and accelerating tissue regeneration, leading to faster healing and improved cosmetic outcomes.

For scientific reference list scan the QR code

EXTENDED SPECTRUM OF CARE

TECHNICAL SPECIFICATIONS

BIOPTRON® Hyperlight has been accepted as a form of DISEASE PREVENTION, THERAPY, and RECOVERY for various medical indications: (See scientific reference list)

The 3 BIOPTRON® devices, BIOPTRON® MedAll, BIOPTRON® Pro 1, and BIOPTRON® 2 differ in size, design, and settings, but feature identical physical light characteristics. 1. Polarized: ensures optimal body penetration. Fullerene C60-mediated light modification optimizes photobiomodulation of tissues. 2. Polychromatic: includes all beneficial effects of all visible and infrared radiation (wavelength from 400–3400 nm excluding the harmful UV light). 3. Incoherent: ensures a safe application. 4. Low energy: allows precise, consistent, and steady dosing of safe light.

Dermatology • Acne • Acne rosacea • Psoriasis • Dermatitis (Eczema) • Herpes simplex • Herpes zoster (Shingles) • Superficial mucosal lesions Pain relief Rheumatology • Osteoarthritis • Arthrosis • Rheumatoid arthritis Physiotherapy • Shoulder pain • Neck pain • Low back pain • Carpal tunnel syndrome • Scar tissue • Musculoskeletal injuries Sports medicine • Muscle spasm • Sprains • Strains • Tendonitis (including Tennis elbow) • Contusions • Desmorrhexis (ligament tear) • Myorrhexis (muscle tear) • Pain due to muscular contraction Pediatrics • Pediatric dermal affections • Endogenous eczema • Upper respiratory tract infections • Allergic respiratory diseases • Pediatric musculoskeletal disorders and neurological disorders and deﬁcits In newborns • Dermal problems (e.g. phlebitis, decubitus, intertrigo)

Seasonal affective disorder (SAD) and depression • Typical winter depression symptoms • Chronic fatigue syndrome • Lowered motivation • Asthenic conditions • Nervous breakdown

BIOPTRON® MEDALL

Veterinary care • Skin problems (e.g. trichophytia, alopecia, bacterial and allergic dermatitis, demodicosis, eczema) • Allergies • Arthritis • Pain • Cramping syndrome • Inflammatory disorders (e.g. otitis externa, mastitis, etc.) • Acute inflammation after surgery and injuries. • Wound healing after surgery and injuries • Saddle sores (horses) • Muscular diseases (Myositis eosinophilica) • Cat flu

Filter Diameter Approx. BIOPTRON® MedAll

5 cm

BIOPTRON® Pro 1

11 cm

BIOPTRON® 2

15 cm

Rated Power of Halogen BIOPTRON® MedAll

20 W

BIOPTRON® Pro 1

50 W

BIOPTRON® 2

75 W

Protective Class BIOPTRON® PRO 1 WITH TABLE STAND

BIOPTRON® MedAll

Class II, IP 20

BIOPTRON® Pro 1

Class II, IP 20

BIOPTRON® 2

Class II, IP 20

Weight

Oral care • Superficial mucosal lesions

BIOPTRON® MedAll (without stand)

0.4 kg

BIOPTRON® MedAll (with stand)

1.9 kg

BIOPTRON® Pro 1 (with table stand)

3.5 kg

BIOPTRON® Pro 1 (with floor stand)

8.1 kg

BIOPTRON® 2 (without stand)

4.2 kg

BIOPTRON® 2 (with floor stand)

11.5 kg

Ambient Temperatures BIOPTRON® 2

Operation

+10 °C to +30 °C

Storage

0 °C to +40 °C

Wavelength

480-3400 nm with edge filter 350-3400 nm with HO filter

Degree of Polarization

>95% (590-1550 nm)

Light Intensity

min. 10,000 lux

Specific Power Density

~ 40 mW/cm2

Light Energy per Minute

~ 2.4 J/cm2

CE Labelling

For further information scan the QR code

1639

Clinically tested, medically certified, and trusted by professionals worldwide, the BIOPTRON® Hyperlight therapy system is more than a device—it’s a revolution in healing. Used daily by physicians, nurses, and wellness experts in hospitals and clinics—and increasingly by individuals and families at home—BIOPTRON® delivers safe, non-invasive, and effective treatment that supports the body’s natural regeneration processes.

For further information scan the QR code

BIOPTRON® AG Sihleggstrasse 23 CH-8832 Wollerau, Switzerland Phone: +41 43 888 28 00 Email: light@bioptron.com www.bioptron.com

Since 1988, BIOPTRON® has stood at the forefront of scientific innovation—merging breakthroughs in physics, chemistry, and medical research to develop state-of-the-art light therapy systems.